Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Chroma Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Chroma Therapeutics
ClinicalTrials.gov Identifier:
NCT01180426
First received: August 5, 2010
Last updated: February 14, 2012
Last verified: February 2012

August 5, 2010
February 14, 2012
June 2010
June 2013   (final data collection date for primary outcome measure)
Safety and Tolerability of extended treatment with tosedostat [ Time Frame: Protocol mandated visits every 12 weeks ] [ Designated as safety issue: Yes ]

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
Same as current
Complete list of historical versions of study NCT01180426 on ClinicalTrials.gov Archive Site
Efficacy of extended treatment with tosedostat [ Time Frame: Protocol-mandated visits every 12 weeks ] [ Designated as safety issue: No ]

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.
Efficay of extended treatment with tosedostat [ Time Frame: Protocol-mandated visits every 12 weeks ] [ Designated as safety issue: No ]

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.
Not Provided
Not Provided
 
Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia
The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
Drug: CHR-2797
120mg once daily oral for 48 weeks
Experimental: Tosedostat
Intervention: Drug: CHR-2797
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01180426
CHR-2797-045
Yes
Chroma Therapeutics
Chroma Therapeutics
Not Provided
Not Provided
Chroma Therapeutics
February 2012

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