A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Recruiting in Palo Alto (17 mi)
+74 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Gemin X
No Placebo Group
Trial Summary
What is the purpose of this trial?
The Phase I portion of this protocol will determine the best phase II dose and schedule of obatoclax with carboplatin and etoposide in patients with extensive-stage small cell lung cancer. The Phase II portion will evaluate the response rate to this regimen.
Research Team
JV
Jean Viallet, MD
Principal Investigator
Gemin X Pharmaceuticals
Eligibility Criteria
Inclusion Criteria
ES-SCLC
Normal organ function defined as: absolute neutrophil count (ANC)
Pathological or cytological confirmation of SCLC
See 7 more
Treatment Details
Interventions
- Carboplatin/Etoposide (Alkylating agents, Topoisomerase I inhibitors)
- Obatoclax (Bcl-2 Inhibitor)
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Phase II AExperimental Treatment2 Interventions
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
Group II: Phase I BExperimental Treatment2 Interventions
Obatoclax for 24 hours for 3 days with carboplatin/etoposide.
Group III: Phase I AExperimental Treatment2 Interventions
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
Group IV: Phase II BActive Control1 Intervention
Carboplatin/etoposide without continued study treatment
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Who Is Running the Clinical Trial?
Gemin X
Lead Sponsor
Trials
13
Recruited
450+
Cephalon
Industry Sponsor
Trials
157
Recruited
18,900+
Robert Schott
Cephalon
Chief Medical Officer since 2023
MD from University of Michigan Medical School
J. Kevin Buchi
Cephalon
Chief Executive Officer since 2010
BA in Chemistry from Cornell University, MBA from Northwestern University