NCT00405951

A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered Every 3 Weeks in Combination With Docetaxel to Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

Completed Phase 1/Phase 2 Last updated 19 July 2016

What this trial tests

Phase 1/Phase 2 trial testing Obatoclax mesylate 250 ml in Lung Cancer in 47 participants. Completed in 1 September 2009.

Timeline

1 October 2006

Primary endpoint
1 November 2008

1 September 2009

Quick facts

Lead sponsor	Gemin X
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	1 October 2006
Primary completion	1 November 2008
Estimated completion	1 September 2009
Sites	7 locations across United States

Drugs / interventions tested

• Obatoclax mesylate 250 ml — full drug profile →
• Docetaxel (Docetaxel) — full drug profile →

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Gemin X — full company profile →

Who can join

18 and older, any sex, with 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.

• RECIST criteria with at least one lesion equal to or greater than 2.0cm using conventional technique or equal to greater than 1.0cm with spiral comupted tomography (CT) scan in a single dimension
  Time frame: 18 months
  Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.

Sponsor's own description

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.

Publications & conference data

6 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. Chemosensitization of prostate cancer by modulating Bcl-2 family proteins.
   Karnak D, Xu L. · · 2010 · cited 63× · PMID 20298153 · DOI 10.2174/138945010791170888
3. 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
4. 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
5. Obatoclax mesylate, a pan-bcl-2 inhibitor, in combination with docetaxel in a phase 1/2 trial in relapsed non-small-cell lung cancer.
   Chiappori A, Williams C, Northfelt DW, Adams JW, et al · · 2014 · cited 26× · PMID 24346101 · DOI 10.1097/jto.0000000000000027
6. BCL-2 and BCL-xL in Cancer: Regulation, Function, and Therapeutic Targeting.
   Silva JPN, Pinto B, Silva PMA, Bousbaa H. · · 2026 · cited 1× · PMID 41596764 · DOI 10.3390/ijms27021123