Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

Chroma Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: CHR-2797

Study type: Interventional

Funder types: Industry

Identifiers

NCT01180426

CHR-2797-045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Tosedostat

Experimental group

Treatment:

Drug: CHR-2797