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Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

The purpose of the study is to test a new investigational compound, called FPA008, which may eventually be used for the treatment of pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT) and possibly for other disorders such as cancer. FPA008 is an experimental drug being developed by FivePrime, a biopharmaceutical company based in the United States (US). This study consists of two phases, Phase 1 and Phase 2. Phase 1 of the study will enroll approximately 12-15 patients who have PVNS/dt-TGCT, and different doses of FPA008 will be tested in Phase 1. Phase 2 of the study will start after a safety review committee reviews data from Phase 1, and a single dose level is chosen for Phase 2 that is considered to be safe.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Five Prime Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: FPA008

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially
   resectable tumor that would result in unacceptable functional loss or morbidity as
   determined by a qualified surgeon or multi-disciplinary tumor board (must be
   documented in the CRF during screening)

   - Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

   - ECOG performance status <1

Exclusion Criteria:

   - Prior therapy with an anti-CSF1R antibody

   - Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression
   on prior kinase inhibitor)

   - Liver function tests (including ALT, AST, and total bilirubin), outside of the range
   of local laboratory normal at Screening

   - Inadequate organ or bone marrow function

   - History of congestive heart failure or myocardial infarction <1 year prior to first
   study dose administration

   - Significant abnormalities on ECG at Screening

   - Contraindications to MRI and use of intravenous gadolinium-based contrast agents

   - Creatine Kinase ≥ 1.5x the upper limit of normal

   - Positive test for latent TB at Screening (Quantiferon test)

   - Active known or suspected autoimmune disease

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting