Entry Detail
| General information | |
| Database: | DB00867 |
| Objective: | The proapoptotic smallmolecule panBcl2 inhibitor obatoclax mesylate (GX15070) may enhance the cytotoxicity of chemotherapy in relapsed/refractory non small cell lung cancer (non small cell lung cancer). |
| Authors: | Chiappori A, et al |
| Title: | Obatoclax mesylate, a panbcl2 inhibitor, in combination with docetaxel in a phase 1/2 trial in relapsed non small cell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2014 |
| PMID: | 24346101 |
| Trial Design | |
| Clinical Trial Id: | NCT00405951 |
| Agent: | obatoclax |
| Target: | Apoptosis regulator BclX Apoptosis regulator Bcl2 Induced myeloid leukemia cell differentiation protein Mcl1 |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Obatoclax mesylate+docetaxel |
| Study Type: | a phase I/II trial |
| Key Patients Feature: | patients with relapsed or refractory non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | docetaxel as a 1hour infusion on day 1 and obatoclax as a 24hour infusion on days 1 and 2every 3 weeks for up to eight cycles. Four dose levels were evaluated inphase 1 (level 1: docetaxel 55 mg/m ¡Á 1 and obatoclax 30 mg ¡Á 2; levels 24: docetaxel 75 mg/m and obatoclax 30 mg, 45 mg, or 60 mg ¡Á 2) to identify doselimiting toxicity and a phase 2 dose. Inphase 2, response and tolerability were evaluated. |
| Primary End Point: | DLTs, MDT, PFS, and adverse events |
| Secondary End Point: | NA |
| Patients Number: | 18 |
| Trial Results | |
| DLT_MTD: | DLTs were defined as grade 3 or higher neurologic adverse event (AE), grade 4 febrile neutropenia or thrombocytopenia, grade 4 neutropenia for 7 days or more, and other grade 3/4 nonhematologic toxicity not ameliorated by symptomdirected therapy. If DLTs occurred, treatment was modified. |
| Objective Response Rate: | 11% (95% CI 2.35-29.16) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.4 months (95% CI 1.2-3.4). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Combined obatoclax mesylate plus docetaxel is tolerable in patients with non small cell lung cancer, but response was minimal and neutropenia was a common adverse event. |