Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Gemin X
Study ID
NCT00427856
Phase
PHASE2
Status
Completed

Conditions

  • Lymphoma, Follicular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obatoclax mesylate — DRUG
    Obatoclax mesylate 40mg, and 60mg
  • Rituximab — DRUG
    Rituximab

Study Details

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.

Key Dates

Start date
Mar 31, 2007
Status verified
Jul 2016
Primary completion
Feb 28, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Obatoclax mesylate 40mg
    40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
  • Experimental: Obatoclax mesylate 60mg
    60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax

Primary Outcome Measure

Response rate [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-

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The Cancer Center at Hackensack University Medical Center· Hackensack, NJ

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