Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Synta Pharmaceuticals Corp..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Synta Pharmaceuticals Corp.
Information provided by:
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01280786
First received: January 14, 2011
Last updated: January 31, 2011
Last verified: January 2011
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Purpose
This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia |
Drug: Elesclomol Sodium |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia |
Resource links provided by NLM:
Further study details as provided by Synta Pharmaceuticals Corp.:
Primary Outcome Measures:
- Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]- Characterize the safety and tolerability of elesclomol sodium administered to subjects with relapsed or refractory acute myeloid leukemia (AML)
- Measurement of study drug concentrations to characterize pharmacokinetics. [ Time Frame: 1 year ] [ Designated as safety issue: No ]- Determination of PK of elesclomol and elesclomol metabolites in subjects with relapsed or refractory acute myeloid leukemia (AML).
Secondary Outcome Measures:
- Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow [ Time Frame: 1 year ] [ Designated as safety issue: No ]- Determine the optimal Phase II dose and preliminary activity for elesclomol sodium in subjects with acute myeloid leukemia (AML).
| Estimated Enrollment: | 36 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Elesclomol Sodium |
Drug: Elesclomol Sodium
Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.
|
Detailed Description:
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when administered to patients with advanced myeloid leukemia.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults with cytologically confirmed Acute Myeloid Leukemia (AML) that has relapsed after the completion of induction and/or consolidation therapy or has failed to respond to standard induction therapy
- ECOG performance status of 0-2
- Acceptable organ and marrow function during the screening period as defined by the protocol
- Reliable venous access suitable for study drug infusions
Exclusion Criteria:
- Significant cardiovascular disease
- Candidates for hematopoietic stem cell transplant
- Women who are pregnant or breast-feeding
- Prior treatment with chronic immunosuppressants
- Other clinically significant uncontrolled conditions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280786
Contacts
| Contact: Joelle Lufkin, MPH | 781 541 7141 | jlufkin@syntapharma.com |
| Contact: Amy Gauger | 781 541 7985 | agauger@syntapharma.com |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Not yet recruiting |
| New York, New York, United States, 10065 | |
| Contact: Mark Heaney, MD, PhD 212-639-2275 m-heaney@ski.mskcc.org | |
| Principal Investigator: Mark Heaney, MD, PhD | |
| Canada, Ontario | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, MSG 2M9 | |
| Contact: Deborah Sanfelice 416-946-4501 ext x2867 Deborah.Sanfelice@uhn.on.ca | |
| Principal Investigator: Aaron Schimmer, MD, PhD | |
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
More Information
No publications provided
| Responsible Party: | Vojo Vukovic, Chief Medical Officer, Synta Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01280786 History of Changes |
| Other Study ID Numbers: | Synta 4783-14 |
| Study First Received: | January 14, 2011 |
| Last Updated: | January 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Synta Pharmaceuticals Corp.:
|
AML leukemia relapsed or refractory AML |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013