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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 group

Complete remission rate at induction completion

Overall remission rate at induction completion

Partial remission rate at induction completion

Secondary outcome:

Study drug administration

Duration 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

Page last updated: August 20, 2015

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