Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies
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ClinicalTrials.gov Identifier: NCT00438178 |
Recruitment Status
:
Completed
First Posted
: February 22, 2007
Last Update Posted
: May 12, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hematological Malignancies | Drug: Obatoclax mesylate (GX15-070MS) | Phase 1 |
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 |

- Determine the recommended Phase II dose of GX15-070MS; Characterize the DLTs of GX15-070MS; Determine the PK/PD response to GX15-070MS
- Describe any clinical responses of patient with hematological malignancies.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 History of Changes |
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:
Neoplasms |