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Also known as M200 (Volociximab), Carboplatin, Paclitaxel, M200 (Volociximab), M200
M200, Carboplatin, Paclitaxel · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Escalating doses of volociximab at 10, 20, and 30 (or 15) mg/kg with carboplatin and paclitaxel. |
| Cohort 1 | OTHER | Three subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk |
| Cohort 2 | OTHER | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk |
| Group A | OTHER | liposomal doxorubicin, 40 mg/m2 q4wk |
| Group B | OTHER | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule) |
| Group C | OTHER | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule) |
| Name | Type | Description |
|---|---|---|
| M200 (Volociximab), Carboplatin, Paclitaxel | DRUG | Volociximab will be administered via IV infusion at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels during the first cycle. Volociximab will be given for at least 6 cycles (3 weeks/cycle) and subjects who have stable disease at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All three drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin. |
| M200 (Volociximab) | DRUG | 7.5 mg/kg, IV infusion every week until disease progression |
| Liposomal Doxorubicin | DRUG | 40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12. |
Inclusion Criteria 1. Males and females at least 18 years of age. 2. Stage IIIB or IV or recurrent NSCLC. 3. Measurable and/or evaluable disease according to RECIST. 4. No prior chemotherapy, biological therapy or immunotherapy for Stage IIIB/IV disease. Adjuvant therapy for early stage disease mus...
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M200, also known as volociximab, has been studied in oncology for advanced non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer. It was evaluated in combination with carboplatin and paclitaxel in first-line NSCLC and with liposomal doxorubicin in ovarian and primary peritoneal cancers. It is an investigational monoclonal antibody and is not approved for any indication.
M200 (volociximab) is a monoclonal antibody. No molecular target is specified in the available information, so its precise mechanism of action cannot be described here. It was developed as an oncology therapeutic and studied in combination with chemotherapy agents such as carboplatin, paclitaxel, and liposomal doxorubicin.
M200 (volociximab) was developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. The company sponsored the clinical trials evaluating M200 in combination with carboplatin and paclitaxel for non-small cell lung cancer and with liposomal doxorubicin for ovarian and primary peritoneal cancers.
M200 (volociximab) is in Phase 1 development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The clinical program includes completed Phase 1 trials in non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer.
M200 (volociximab) has been studied in two completed Phase 1 trials. NCT00654758 evaluated M200 with carboplatin and paclitaxel in first-line advanced non-small cell lung cancer and enrolled 33 patients. NCT00635193 evaluated M200 with liposomal doxorubicin in ovarian and primary peritoneal cancer and enrolled 138 patients across multiple countries.
Yes, M200 is also known as volociximab. The names refer to the same monoclonal antibody developed by AbbVie Inc. for oncology indications including non-small cell lung cancer, ovarian cancer, and primary peritoneal cancer. It has been investigated in Phase 1 clinical trials in combination with chemotherapy.