Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells. This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 21, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Gemin X
- Interventions being studied
- Drug: Obatoclax mesylate 250 ml; Drug: Docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Pathological confirmation of Non-Small Cell Lung Cancer (NSCLC)
- Must have been previously treated with a single platinum-based chemotherapy regimen and shown evidence of disease progression; no further limitations
- Must have normal organ function
- Must be willing to submit to blood sampling for planned PK and PD analysis
- Must have the ability to understand and willingness to sign a written informed consent form
- No other agents or therapies administered with the intent to treat malignancy
- Patients with prior exposure to obatoclax or docetaxel
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic College of MedicineScottsdale, Arizona
- Tower OncologyBeverly Hills, California
- Georgetown UniversityWashington D.C., District of Columbia
- H. Lee Moffitt Cancer CenterTampa, Florida
- University of MarylandBaltimore, Maryland
- MedStar Research InstituteBaltimore, Maryland
- Arlington Cancer CenterArlington, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 21, 2016. Always confirm current availability with the study team.