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Trial record 1 of 30 for:    TOPAZ study
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Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01180426
Recruitment Status : Unknown
Verified February 2012 by Chroma Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2010
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Chroma Therapeutics

Tracking Information
First Submitted Date  ICMJE August 5, 2010
First Posted Date  ICMJE August 12, 2010
Last Update Posted Date February 15, 2012
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Safety and Tolerability of extended treatment with tosedostat [ Time Frame: Protocol mandated visits every 12 weeks ]
Primary outcome will be assessed using the following procedures/data:
  • Physical exams
  • Vital signs
  • Electrocardiography
  • Laboratory parameters (hematology, chemistry, urinalysis)
  • Adverse events
  • Serious adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
Efficacy of extended treatment with tosedostat [ Time Frame: Protocol-mandated visits every 12 weeks ]
The secondary outcome will be assessed using the following parameters:
  • Overall survival
  • Relapse-free survival
  • Event-free survival
  • Clinical responses (Complete Remission, Complete Remission with Incomplete Platelet Recovery, Morphological Leukemia-Free State, Partial Remission, Stable Disease, Progressive Disease) including best response and time to response
  • Duration of clinical responses.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Efficay of extended treatment with tosedostat [ Time Frame: Protocol-mandated visits every 12 weeks ]
The secondary outcome will be assessed using the following parameters:
  • Overall survival
  • Relapse-free survival
  • Event-free survival
  • Clinical responses (Complete Remission, Complete Remission with Incomplete Platelet Recovery, Morphological Leukemia-Free State, Partial Remission, Stable Disease, Progressive Disease) including best response and time to response
  • Duration of clinical responses.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia
Official Title  ICMJE The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat
Brief Summary The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.
Detailed Description

Extension protocol to the OPAL Study (CHR-2797-038).

Study mimics normal clinical practice; few procedures and visits are therefore mandated by the protocol. Timing of bone marrow assessment is also left at the investigator's discretion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE Drug: CHR-2797
120mg once daily oral for 48 weeks
Study Arms  ICMJE Experimental: Tosedostat
Intervention: Drug: CHR-2797
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed, informed consent
  • Completion of Visit 11 in the OPAL Study (Month 6 Visit)
  • Investigator's opinion that the subject would benefit from continued therapy with tosedostat.

Exclusion Criteria:

  • Any co-existing medical condition that in the Investigator's opinion will substantially increase the risk associated with the subject's participation in the study
  • Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
  • Administration of any (other) investigational agent within 14 days of entry into TOPAZ.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01180426
Other Study ID Numbers  ICMJE CHR-2797-045
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chroma Therapeutics
Study Sponsor  ICMJE Chroma Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chroma Therapeutics
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP