NCT00682981

A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide With or Without Obatoclax Administered Every 3 Weeks to Patients With Extensive- Stage Small Cell Lung Cancer (ES-SCLC)

Completed Phase 1/Phase 2 Last updated 19 July 2016

What this trial tests

Phase 1/Phase 2 trial testing Obatoclax in Extensive-stage Small Cell Lung Cancer in 218 participants. Completed in 1 November 2011.

Timeline

1 May 2008

Primary endpoint
1 November 2011

1 November 2011

Quick facts

Lead sponsor	Gemin X
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	218
Start date	1 May 2008
Primary completion	1 November 2011
Estimated completion	1 November 2011
Sites	75 locations across United States, Bulgaria, Canada, Czechia, Hungary, India, Poland, Romania

Drugs / interventions tested

• Obatoclax — full drug profile →
• Carboplatin/etoposide

Conditions studied

• Extensive-stage Small Cell Lung Cancer — all drugs for Extensive-stage Small Cell Lung Cancer →

Sponsor

Gemin X — full company profile →

Who can join

18 and older, any sex, with Extensive-stage Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Determine the recommended Phase II dose of obatoclax administered as a 3-hour or 24-hour infusion for 3 consecutive days in Phase I, and response rate in Phase II.
  Time frame: 6 months

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. BH3-mimetics: recent developments in cancer therapy.
   Townsend PA, Kozhevnikova MV, Cexus ONF, Zamyatnin AA, et al · · 2021 · cited 70× · PMID 34753495 · DOI 10.1186/s13046-021-02157-5
2. Bcl-2 pathway inhibition in solid tumors: a review of clinical trials.
   Ploumaki I, Triantafyllou E, Koumprentziotis IA, Karampinos K, et al · · 2023 · cited 60× · PMID 36639602 · DOI 10.1007/s12094-022-03070-9
3. Ionophores: Potential Use as Anticancer Drugs and Chemosensitizers.
   Kaushik V, Yakisich JS, Kumar A, Azad N, et al · · 2018 · cited 58× · PMID 30262730 · DOI 10.3390/cancers10100360
4. A phase I trial of pan-Bcl-2 antagonist obatoclax administered as a 3-h or a 24-h infusion in combination with carboplatin and etoposide in patients with extensive-stage small cell lung cancer.
   Chiappori AA, Schreeder MT, Moezi MM, Stephenson JJ, et al · · 2012 · cited 41× · PMID 22333598 · DOI 10.1038/bjc.2012.21
5. Targeted therapies in small cell lung cancer: a review.
   Abidin AZ, Garassino MC, Califano R, Harle A, et al · · 2010 · cited 36× · PMID 21789124 · DOI 10.1177/1758834009356014
6. Optimization of circulating biomarkers of obatoclax-induced cell death in patients with small cell lung cancer.
   Dean EJ, Cummings J, Roulston A, Berger M, et al · · 2011 · cited 18× · PMID 21472138 · DOI 10.1593/neo.101524
7. Unlocking the Potential of Pyrrole: Recent Advances in New Pyrrole-Containing Compounds with Antibacterial Potential.
   Rusu A, Oancea OL, Tanase C, Uncu L. · · 2024 · cited 8× · PMID 39684580 · DOI 10.3390/ijms252312873
8. Small cell lung cancer: emerging subtypes, signaling pathways, and therapeutic vulnerabilities.
   Zhang J, Zeng X, Guo Q, Sheng Z, et al · · 2024 · cited 8× · PMID 39103941 · DOI 10.1186/s40164-024-00548-w