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Also known as Obatoclax mesylate (GX15-070MS), Obatoclax mesylate, GX15-070MS
Obatoclax · 10 trials · 10 indications
Determine the response rate according to bone marrow blast count less than or equal to 10%
Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | In the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax. |
| Obatoclax mesylate 40mg | EXPERIMENTAL | 40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax |
| Obatoclax mesylate 60mg | EXPERIMENTAL | 60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax |
| Obatoclax Mesylate | EXPERIMENTAL | Obatoclax Mesylate 60mg |
| GX15-070MS | EXPERIMENTAL | Obatoclax mesylate 60mg |
| Phase I A | EXPERIMENTAL | Obatoclax for 3 hours for 3 days with carboplatin/etoposide. |
| Phase I B | EXPERIMENTAL | Obatoclax for 24 hours for 3 days with carboplatin/etoposide. |
| Phase II A | EXPERIMENTAL | Obatoclax for 3 hours for 3 days with carboplatin/etoposide. |
| Phase II B | ACTIVE_COMPARATOR | Carboplatin/etoposide without continued study treatment |
| Obatoclax Mesylate + Docetaxel | EXPERIMENTAL | Obatoclax Mesylate 250mL in combination with Docetaxel |
| 1 | EXPERIMENTAL | 30mg obatoclax, 1.0mg/m2 bortezomib |
| 2 | EXPERIMENTAL | obatoclax 30 mg, bortezomib 1.3 mg/m2 |
| 3 | EXPERIMENTAL | Obatoclax 45 mg, Bortezomib 1.3 mg/m2 |
| Name | Type | Description |
|---|---|---|
| Obatoclax | DRUG | A 3-hour IV infusion for 3 consecutive days or a 24-hour infusion for 3 consecutive days every 2 weeks for up to 6 cycles. |
| Obatoclax mesylate | DRUG | Obatoclax mesylate 40mg, and 60mg |
| Rituximab | DRUG | Rituximab |
| Obatoclax mesylate (GX15-070MS) | DRUG | 60 mg q2wks |
| GX15-070MS | DRUG | A 60-minute or 3-hour IV infusion every 2-3 weeks. |
| Carboplatin/etoposide | DRUG | Carboplatin/etoposide combination |
| Obatoclax mesylate 250 ml | DRUG | - |
| Docetaxel | DRUG | - |
| Bortezomib | DRUG | 1.0mg/m2, 1.3 mg/m2 |
Inclusion Criteria: * Histologically or cytologically confirmed AML * No prior chemotherapy for AML (with the exception that the patients enrolled in the Pilot Safety evaluation may have had 1 prior therapy) * Age ≥70 years * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 * Patient...
Obatoclax is an investigational small molecule studied in several cancers, including acute myeloid leukemia, extensive-stage small cell lung cancer, hematological malignancies, and follicular lymphoma. It has been evaluated both as a single agent and in combination with chemotherapy or rituximab. It is not an approved therapy and remains in clinical development.
Obatoclax is a small molecule inhibitor that targets the BCL2 family of anti-apoptotic proteins, including BCL2, BCL2L2, BCL2L2-PABPN1, BCL2A1, MCL1, and BCL2L1. By inhibiting these proteins, it is designed to promote apoptosis, or programmed cell death, in cancer cells.
Obatoclax is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor associated with the clinical trials evaluating the drug across hematological and solid tumor indications.
Obatoclax is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. Its trials have spanned Phase 1 and Phase 2 studies, and all listed studies have been completed.
Obatoclax has been studied in completed trials including NCT00684918 in previously untreated acute myeloid leukemia, NCT00682981 in extensive-stage small cell lung cancer, NCT00438178 in hematological malignancies, and NCT00427856 in previously untreated follicular lymphoma. These studies evaluated safety and efficacy across these cancer types.
Yes. Obatoclax mesylate is the mesylate salt form of Obatoclax and is also referred to as GX15-070MS. The names Obatoclax, Obatoclax mesylate, and Obatoclax mesylate (GX15-070MS) refer to the same investigational agent.