Clinical Trials Directory

Trials / Unknown

UnknownNCT03588078

Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of APR-246 in Combination With Azacitidine for the Treatment of Mutation TP53 (TP53) Mutant Myeloid Neoplasms

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
53 (actual)
Sponsor
Groupe Francophone des Myelodysplasies · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The main purpose of this study is to determine the safe and efficacy of APR-246 in combination with azacitidine as well as to see complete remission of this patients

Detailed description

Patients will be treated for a total of 6 cycles.For patients responding or who have stable disease following cycle 6, treatment may continue until one of the following criteria applies: * Inter-current illness that prevent further administration of treatment * Unacceptable adverse event(s) * Participant decides to withdraw from the study, * general or specific changes in the participant's condition render the participant unacceptable for further treatment in the judgment of the investigator. * Evidence of disease progression by international working Group (IWG) 2006 criteria. * participants who wish not to continue treatment at time of disease assessment at end of cycle 6 will complete their end of treatment visit upon completion of cycle 6

Conditions

Interventions

TypeNameDescription
DRUGAPR-246Azacitidine at maximum tolerated dose. APR246 at the Dose limited Toxicity (DLT) dose
DRUGAzacitidineazacitidine is administered subcutaneously (SC) or via IV at 75 mg/m2

Timeline

Start date
2018-09-15
Primary completion
2020-05-01
Completion
2021-05-15
First posted
2018-07-17
Last updated
2020-01-30

Locations

7 sites across 1 country: France

Regulatory

Source: ClinicalTrials.gov record NCT03588078. Inclusion in this directory is not an endorsement.