Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)
Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myeloid Leukemia
Intervention: Entospletinib (Drug); Daunorubicin (Drug); Cytarabine (Drug); Decitabine (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s): Mario Marcondes, MD, PhD, Study Director, Affiliation: Gilead Sciences
Overall contact: Gilead Study Team, Email: GS9973alerts@gilead.com
Summary
This study will evaluate the efficacy, safety, tolerability, and pharmacodynamics of
entospletinib (GS-9973) when administered as monotherapy or in combination with chemotherapy
in adults with acute myeloid leukemia (AML).
Clinical Details
Official title: A Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination With Chemotherapy in Subjects With Acute Myeloid Leukemia (AML)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Occurrence of adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLTs) for each treatment groupComplete remission rate at induction completion Overall remission rate at induction completion Partial remission rate at induction completion
Secondary outcome: Study drug administrationDuration of exposure of study treatment Occurrence of AEs and laboratory abnormalities not defined as DLTs
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults with AML in need of treatment (except individuals with acute promyelocytic
leukemia M3)
- Individuals ≥ 18 and < 60 years of age with previously untreated AML by World Health
Organization (WHO) criteria
- Individuals between 60 to 70 years of age are eligible regardless of risk group
- Individuals > 70 years of age with previously untreated AML
- Individuals ≤ 70 years of age with previously untreated AML who refuse or are unable
to receive daunorubicin and cytarabine (3+7) chemotherapy as determined by the
treating physician
Exclusion Criteria:
- Known active central nervous system or leptomeningeal lymphoma
Locations and Contacts
Gilead Study Team, Email: GS9973alerts@gilead.com
Ohio State University, Columbus, Ohio, United States; Recruiting
Additional Information
Starting date: June 2015
Last updated: July 24, 2015
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