Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)
A Multi-Center, Open-Label, Phase II Study of Sequential, Single-Agent Obatoclax Mesylate (GX15-070MS)Followed by a Combination With Rituximab to Patients With Previously-Untreated Follicular Lymphoma (FL)
1 other identifier
interventional
7
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2007
CompletedFirst Posted
Study publicly available on registry
January 29, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJuly 22, 2016
July 1, 2016
1.9 years
January 25, 2007
July 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate
12 weeks
Secondary Outcomes (1)
Time to Tumor Progression.
20 weeks
Study Arms (2)
Obatoclax mesylate 40mg
EXPERIMENTAL40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
Obatoclax mesylate 60mg
EXPERIMENTAL60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
Interventions
Obatoclax mesylate 40mg, and 60mg
Eligibility Criteria
You may qualify if:
- Pathological confirmation of Follicular Lymphoma (FL)
- Must have advanced stage disease
- Must not have received any prior chemotherapy or immunotherapy for lymphoma, including steroids
- Must have adequate organ function
- Must have the ability to understand and willingness to sign a written informed consent form
You may not qualify if:
- No other agents or therapies administered with the intent to treat malignancy
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gemin Xlead
Study Sites (1)
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean Viallet, MD
Gemin X, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2007
First Posted
January 29, 2007
Study Start
March 1, 2007
Primary Completion
February 1, 2009
Study Completion
July 1, 2009
Last Updated
July 22, 2016
Record last verified: 2016-07