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Trial was terminated to allow sponsors to evaluate the future development of the drug program
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| Name | Class |
|---|---|
| Agensys, Inc. | INDUSTRY |
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This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.
All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. PLD plus AGS-8M4 | Experimental | Women with platinum resistent ovarian cancer |
|
| B. Carboplatin and gemcitabine plus AGS-8M4 | Experimental | Women with platinum sensitive ovarian cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGS-8M4 | Biological | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Throughout the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK variables | Treatment Arm A: Weeks 1 and 3 of each cycle. Treatment Arm B: Week 1 of each cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits. | |
| Incidence of anti-AGS-8M4 antibody formation | Treatment Arm A: Day 1 of every other cycle and at Day 15 for the first cycle only. Treatment Arm B: Day 1 of every other cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Agensys, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duarte | California | 91010 | United States |
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| Pegylated liposomal doxorubicin (PLD) | Drug | IV infusion |
|
| gemcitabine | Drug | IV infusion |
|
| carboplatin | Drug | IV infusion |
|
| Changes in tumor status per RECIST | Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks. |
| Change in CA-125 levels | Treatment Arm A: Day 1 and Day 15 of each cycle. Treatment Arm B: Day 1 of each cycle. In addition, samples will be drawn at the Safety F/U. |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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