An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study

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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of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.

Sex

All

Minimum age

18 Years

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.

• RESULTBarrientos 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.
• RESULTBarrientos 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.
• RESULTBarrientos 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.
• RESULTBarrientos 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.
• RESULTBenson D, Kahl BS, et al. (2013). Final Results of a Phase 1 Study of Idelalisib, a Selective Inhibitor of PI3Kδ, in Patients with Relapsed or Refractory Indolent non-Hodgkin Lymphoma [Presentation]. ASCO Annual Meeting, Chicago, Illinois.
• RESULTBrown JR, Cheson BD, et al. (2015). Patterns of Lymphocytosis in Patients with CLL or Small Lymphocytic Lymphoma (SLL) Treated with Idelalisib. 57th ASH Annual Meeting and Exposition, Orlando, Florida.
• RESULTBrown JR, Byrd JC, Coutre SE, Benson DM, Flinn IW, Wagner-Johnston ND, Spurgeon SE, Kahl BS, Bello C, Webb HK, Johnson DM, Peterman S, Li D, Jahn TM, Lannutti BJ, Ulrich RG, Yu AS, Miller LL, Furman RR. Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110delta, for relapsed/refractory chronic lymphocytic leukemia. Blood. 2014 May 29;123(22):3390-7. doi: 10.1182/blood-2013-11-535047. Epub 2014 Mar 10.