|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00438178 |
|
Date of registration:
|
21/02/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies
|
|
Scientific 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 |
|
Date of first enrolment:
|
October 2005 |
|
Target sample size:
|
44 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00438178 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Canada
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Jean Viallet, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Gemin X, Inc. |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hematological Malignancies
|
|
Intervention(s)
|
|
Drug: Obatoclax mesylate (GX15-070MS)
|
|
Primary Outcome(s)
|
|
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(s)
|
|
Describe any clinical responses of patient with hematological malignancies.
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|