Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Obatoclax
GX15-070MS · 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...
GX15-070MS is an investigational small molecule being studied for the treatment of chronic lymphocytic leukemia (CLL), a type of blood cancer. It has been evaluated specifically in previously untreated CLL patients. The drug is in Phase 1 clinical development and is not approved for any indication.
GX15-070MS is being developed by Teva Pharmaceutical Industries Limited, which trades on the New York Stock Exchange under the ticker TEVA. The company sponsored the clinical trial evaluating the drug in chronic lymphocytic leukemia.
GX15-070MS is in Phase 1 clinical development. It has completed one Phase 1/2 trial in chronic lymphocytic leukemia, and there are currently no active trials listed for this drug. It is investigational and has not received FDA approval.
GX15-070MS has been studied in one completed clinical trial: NCT00600964, titled "A Phase I/II Study of GX15-070MS in Untreated CLL." The trial enrolled 26 participants across the United States and Canada and evaluated the drug in adults with chronic lymphocytic leukemia.
No, GX15-070MS is not FDA approved. It remains an investigational drug in Phase 1 clinical development for chronic lymphocytic leukemia. The only completed trial was an early-stage study, and no regulatory approval has been granted for this asset.