- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00427856
Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)
July 20, 2016 updated by: Gemin X
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a multi-center, open-label, Phase II study of obatoclax administered alone as a weekly, 3-hour or 24-hour infusion for 12 weeks followed by a combination with rituximab to patients with previously-untreated Follicular Lymphoma.
For purposes of clinical evaluations, treatment cycles will occur in 4-week periods.
Treatment may be administered on an outpatient basis.
No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- The Cancer Center at Hackensack University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- No other agents or therapies administered with the intent to treat malignancy
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Rituximab
Obatoclax mesylate 40mg, and 60mg
Other Names:
|
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
|
Rituximab
Obatoclax mesylate 40mg, and 60mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Tumor Progression.
Time Frame: 20 weeks
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jean Viallet, MD, Gemin X, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
January 25, 2007
First Submitted That Met QC Criteria
January 26, 2007
First Posted (Estimate)
January 29, 2007
Study Record Updates
Last Update Posted (Estimate)
July 22, 2016
Last Update Submitted That Met QC Criteria
July 20, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Follicular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
- Obatoclax
Other Study ID Numbers
- GEM014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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