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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00438178
Other study ID # GX006
Secondary ID
Status Completed
Phase Phase 1
First received February 21, 2007
Last updated May 9, 2014
Start date October 2005

Study information

Verified date May 2014
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Obatoclax mesylate (GX15-070MS)


Locations

Country Name City State
Canada Princess Margaret Hospital Toronto Ontario
United States MD Anderson Cancer Center Houston Texas
United States Georgetown University Medical Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Gemin X

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Schimmer AD, O'Brien S, Kantarjian H, Brandwein J, Cheson BD, Minden MD, Yee K, Ravandi F, Giles F, Schuh A, Gupta V, Andreeff M, Koller C, Chang H, Kamel-Reid S, Berger M, Viallet J, Borthakur G. A phase I study of the pan bcl-2 family inhibitor obatocla — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the recommended Phase II dose of GX15-070MS; Characterize the DLTs of GX15-070MS; Determine the PK/PD response to GX15-070MS
Secondary Describe any clinical responses of patient with hematological malignancies.
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