Clinical Trials

Multiple clinical trials spanning Phase I through Phase III have evaluated Obatoclax (GX15-070) across diverse hematologic and solid malignancies, including extensive-stage small cell lung cancer, acute myeloid leukemia, myelofibrosis, metastatic melanoma, chronic lymphocytic leukemia, and non-Hodgkin lymphoma. Sponsored by corporate entities like Gemin X, Cephalon, and Teva alongside major institutions such as the National Cancer Institute and M.D. Anderson Cancer Center, these studies exhibit varied recruitment statuses. Overall outcomes encompass completed investigations as well as studies that were ultimately terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01563601 WITHDRAWN
Extensive-stage Small Cell Lung Cancer
Cephalon
 2012-08 PHASE3
NCT00612612 TERMINATED
B-cell Chronic Lymphocytic Leukemia; Leukemia; Prolymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia
National Cancer Institute (NCI)
 2008-01 PHASE1
NCT00933985 TERMINATED
Acute Leukemias of Ambiguous Lineage; Acute Undifferentiated Leukemia; Angioimmunoblastic T-cell Lymphoma; Blastic Phase Chronic Myelogenous Leukemia; Childhood Burkitt Lymphoma; Childhood Chronic Myelogenous Leukemia; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Relapsing Chronic Myelogenous Leukemia; Small Intestine Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
 2009-06 PHASE1
NCT01238146 WITHDRAWN
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma
National Cancer Institute (NCI)
 2010-10 PHASE1; PHASE2
NCT00682981 COMPLETED
Extensive-stage Small Cell Lung Cancer
Gemin X
 2008-05 PHASE1; PHASE2
NCT00538187 TERMINATED
Adult Non-Hodgkin Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma
National Cancer Institute (NCI)
 2007-12 PHASE1
NCT00719901 TERMINATED
Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
National Cancer Institute (NCI)
 2008-07 PHASE1; PHASE2
NCT00918931 TERMINATED
Leukemia; Systemic Mastocytosis
M.D. Anderson Cancer Center
 2009-06 PHASE2
NCT00521144 COMPLETED
Recurrent Small Cell Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
 2007-08 PHASE1; PHASE2
NCT00684918 COMPLETED
AML
Gemin X
 2008-04 PHASE2
NCT00407303 COMPLETED
Mantle-Cell Lymphoma
Gemin X
 2006-10 PHASE1; PHASE2
NCT00413114 COMPLETED
Myelodysplastic Syndromes
Gemin X
 2006-12 PHASE2
NCT00427856 COMPLETED
Lymphoma, Follicular
Gemin X
 2007-03 PHASE2
NCT00405951 COMPLETED
Lung Cancer
Gemin X
 2006-10 PHASE1; PHASE2
NCT00724841 TERMINATED
Metastatic Melanoma
Gemin X
 2008-06 PHASE1; PHASE2
NCT00682981 Completed
Extensive-stage Small Cell Lung Cancer
Gemin X|Cephalon|Teva Branded Pharmaceutical Products R&D Inc.
 2008-05 Phase 1|Phase 2
NCT00684918 Completed
AML
Gemin X|Teva Branded Pharmaceutical Products R&D Inc.
 2008-04 Phase 2
NCT00360035 COMPLETED
Myelofibrosis
Gemin X
 2006-07 PHASE2
NCT00438178 COMPLETED
Hematological Malignancies
Gemin X
 2005-10 PHASE1
NCT00359892 COMPLETED
Hodgkin's Lymphoma
Gemin X
 2006-07 PHASE2
NCT00600964 COMPLETED
Chronic Lymphocytic Leukemia
Gemin X
 2004-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2012-08-15)

Check the Obatoclax (GX15-070) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Obatoclax (GX15-070) acts as an antagonist of the anti-apoptotic protein Bcl-2 with a Ki of 0.22 µM in cell-free assays, effectively neutralizing pro-survival signaling and overcoming MCL-1-mediated apoptotic resistance. This inhibition restores intrinsic apoptotic pathways to promote cancer cell death, which underpins its evaluated clinical utility in hematologic malignancies such as leukemia and lymphoma as well as solid tumors like small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.