MedTrace Logo

PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (LAM-PIK)

NCT02438761 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-08

No results posted yet for this study

Summary

Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384 (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.

Conditions

  • Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome
  • Acute Myeloid Leukemia, in Relapse
  • de Novo Acute Myeloid Leukemia at Diagnostic

Interventions

DRUG

PF-05212384

PF-05212384 will be delivered by intra-venous route at a fixed dose of 150 mg per week. Each treatment cycle includes four weekly injections The treatment is administered in cycles of 28 days for a period of 4 cycles. Patients will be treated on a weekly basis continuously during 112 days or until progression.

Sponsors & Collaborators

  • Fondation ARC

    collaborator OTHER

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Institut Curie

    lead OTHER

Principal Investigators

  • Jacques Vargaftig, MD · Institut Curie - Hôpital René Huguenin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-05-10
Completion
2018-04-23

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02438761 on ClinicalTrials.gov