Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies
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| ClinicalTrials.gov Identifier: NCT00438178 |
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Recruitment Status :
Completed
First Posted : February 22, 2007
Last Update Posted : May 12, 2014
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Sponsor:
Gemin X
Information provided by:
Teva Pharmaceutical Industries
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hematological Malignancies | Drug: Obatoclax mesylate (GX15-070MS) | Phase 1 |
This is a multi-center, open-label, Phase I study of obatoclax administered every 2-week or weekly cycles, or as a Prolonged Infusion every 2 to 3 weeks to patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML)in Myeloid Blast Phase, Myelofibrosis, Previously-Treated Chronic Lymphocytic Leukemia (CLL), or Aplastic Anemia. Due to the PK/PD sampling schedule Cycle 1 will require overnight hospitalization. For the following cycles treatment may be administered on an outpatient basis but is at the discretion of the investigator. No investigational or commercial agents or therapies other than those described within the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from hematological malignancies are allowed.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Study of Obatoclax Mesylate (GX15-070MS) in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML)in Myeloid Blast Phase, Myelofibrosis, Previously-Treated Chronic Lymphocytic Leukemia (CLL), or Aplastic Anemia |
| Study Start Date : | October 2005 |
| Actual Primary Completion Date : | October 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Primary myelofibrosis
Familial acute myeloid leukemia with mutated CEBPA
Chronic myeloid leukemia
Cytogenetically normal acute myeloid leukemia
Core binding factor acute myeloid leukemia
Primary Outcome Measures :
- Determine the recommended Phase II dose of GX15-070MS; Characterize the DLTs of GX15-070MS; Determine the PK/PD response to GX15-070MS
Secondary Outcome Measures :
- Describe any clinical responses of patient with hematological malignancies.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmation of AML, MDS, CML in blast phase, myelofibrosis, CLL, or aplastic anemia
- There are no limitations on additional, allowable type and amount of prior therapy as long as acute toxicities have resolved to the allowable grade.
- Must have normal organ functions
- Must be willing to submit to blood sampling for the planned PK and PD analyses.
- Must have the ability to understand and willingness to sign a written informed consent form
Exclusion Criteria:
- No other agents or therapies administered for the intent to treat
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438178
Locations
| United States, District of Columbia | |
| Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
Sponsors and Collaborators
Gemin X
Investigators
| Study Director: | Jean Viallet, MD | Gemin X, Inc. |
Publications of Results:
| Responsible Party: | Jean Viallet, MD / Chief Medical Officer, Gemin X Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00438178 |
| Other Study ID Numbers: |
GX006 |
| First Posted: | February 22, 2007 Key Record Dates |
| Last Update Posted: | May 12, 2014 |
| Last Verified: | May 2014 |
Additional relevant MeSH terms:
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Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases |
Obatoclax Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |