Clinical trial NCT01090414: An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study
Official title: An Extension Study to Investigate the Safety and Durability of Clinical Activity of Idelalisib in Subjects With Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Lymphocytic Leukemia
Lymphoma, Non-Hodgkin
Keywords: Idelalisib
Chronic lymphocytic leukemia (CLL)
Non-Hodgkin lymphoma (NHL)
Phosphatidylinositol 3-kinase (PI3K)
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2010-03-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.


Eligibility criteria: Key Inclusion Criteria:

* Patients with hematologic malignancies completing a prior idelalisib study with a clinical benefit are eligible
* Women of childbearing potential must have a negative pregnancy test to be eligible
* Male patients, and female patients of childbearing potential, must agree to use method(s) of contraception specified in the protocol

Key Exclusion Criteria:

* Patients who are unwilling or unable to comply with the protocol are not eligible

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Overall Response Rate
timeFrame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
measure: Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events
timeFrame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days
Secondary outcomes:
measure: Duration of Response
timeFrame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
measure: Progression-Free Survival
timeFrame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
measure: Overall Survival
timeFrame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
measure: Time to Response
timeFrame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: Bethesda
country: United States
facility: Center for Cancer & Blood Disorders, PC
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New Hyde Park
country: United States
facility: Long Island Jewish medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Springfield
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer and Research Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Yakima
country: United States
facility: Yakima Regional Cancer Care
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Barrientos J, Coutre SE, et al. (2014). Long-Term Follow-Up of a Phase 1 Trial of Idelalisib (ZYDELIG®) in Combination with Bendamustine, Bendamustine/Rituximab, Fludarabine, Chlorambucil, or Chlorambucil/Rituximab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) [Abstract 3343]. 56th American Society of Hematology (ASH) Annual Meeting and Exposition, San Francisco, California.
citation: Barrientos JC, Leonard JP, et al. (2013). Update on a Phase 1 Study of the Selective PI3Kδ Inhibitor, Idelalisib (GS-1101) in Combination with Rituximab and/or Bendamustine in Patients with Relapsed or Refractory CLL [Presentation]. American Society for Clinical Oncology (ASCO) Annual Meeting, Chicago, Illinois.
citation: Barrientos JC, Wagner-Johnston ND, et al. (2013). Chemo-Immunotherapy Combination of Idelalisib with Bendamustine/Rituximab or Chlorambucil/Rituximab in Patients with Relapsed/ Refractory CLL Demonstrates Efficacy and Tolerability [Poster 4176]. 55th ASH Annual Meeting and Exposition, New Orleans, Louisiana.
citation: Barrientos JC, Sharman J, et al. (2012). GS-1101 (CAL-101), A Selective Phosphatidylinositol 3-Kinase-Delta Inhibitor, in Combination With Ofatumumab for the Treatment of Relapsed/ Refractory CLL [Abstract 1062]. Haematologica: the Hematology Journal 17th Congress of the European Hematology Association 14-17 June 2012 Amsterdam; Netherlands 97 (Suppl 1): 433.
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