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Obatoclax · 9 trials · 9 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 30mg |
| 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 | - |
| 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 being studied for the treatment of several cancers, including Hodgkin's Lymphoma, acute myeloid leukemia (AML), myelodysplastic syndromes, myelofibrosis, lung cancer, and extensive-stage small cell lung cancer. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.
Obatoclax is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. The drug is an investigational oncology therapy and has not received regulatory approval for any indication.
Obatoclax is in Phase 2 clinical development for multiple oncology indications, including Hodgkin's Lymphoma, AML, and myelofibrosis. It remains investigational and has not been approved by the FDA or other regulatory agencies. Clinical trials are ongoing or completed, but the drug is not yet marketed.
Obatoclax has been studied in several completed clinical trials, including NCT00359892 for Hodgkin's Lymphoma, NCT00360035 for myelofibrosis, NCT00438178 for hematological malignancies, and NCT00684918 for acute myeloid leukemia. These trials were conducted primarily in the United States and Canada.
Yes, Obatoclax is also known as Obatoclax Mesylate (GX15-070MS). Clinical trial records refer to the drug by this alternative name, and it is the same investigational compound being developed by Teva Pharmaceutical Industries Limited.