NCT00407303

A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Completed Phase 1/Phase 2 Last updated 19 July 2016

What this trial tests

Phase 1/Phase 2 trial testing Obatoclax mesylate in Mantle-Cell Lymphoma in 24 participants. Completed in 1 November 2009.

Timeline

1 October 2006

Primary endpoint
1 March 2009

1 November 2009

Quick facts

Lead sponsor	Gemin X
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 October 2006
Primary completion	1 March 2009
Estimated completion	1 November 2009
Sites	5 locations across United States

Drugs / interventions tested

• Obatoclax mesylate — full drug profile →
• Bortezomib (bortezomib) — full drug profile →

Conditions studied

• Mantle-Cell Lymphoma — all drugs for Mantle-Cell Lymphoma →

Sponsor

Gemin X — full company profile →

Who can join

18 and older, any sex, with Mantle-Cell Lymphoma. 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 response rate to obatoclax in combination with Bortezomib and characterize the safety profile
  Time frame: 4 weeks to 2 years

Sponsor's own description

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic 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.

Publications & conference data

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

1. Targeting the Bcl-2 Family in B Cell Lymphoma.
   Adams CM, Clark-Garvey S, Porcu P, Eischen CM. · · 2018 · cited 112× · PMID 30671383 · DOI 10.3389/fonc.2018.00636
2. 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
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/II study of the pan Bcl-2 inhibitor obatoclax mesylate plus bortezomib for relapsed or refractory mantle cell lymphoma.
   Goy A, Hernandez-Ilzaliturri FJ, Kahl B, Ford P, et al · · 2014 · cited 41× · PMID 24679008 · DOI 10.3109/10428194.2014.907891
5. Molecular targeted approaches in mantle cell lymphoma.
   Weniger MA, Wiestner A. · · 2011 · cited 16× · PMID 21782064 · DOI 10.1053/j.seminhematol.2011.05.001
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