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

NCT01090414 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 101-99
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 18

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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion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

Conditions

Chronic Lymphocytic Leukemia; Lymphoma, Non-Hodgkin

Keywords

Idelalisib; Chronic lymphocytic leukemia (CLL); Non-Hodgkin lymphoma (NHL); Phosphatidylinositol 3-kinase (PI3K)

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate

  Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only).

  Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

• Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events

  Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days

Secondary Outcomes (4)

• Duration of Response

  Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

• Progression-Free Survival

  Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

• Overall Survival

  Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

• Time to Response

  Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)

Study Arms (1)

Idelalisib

EXPERIMENTAL

Participants will receive up to 350 mg of idelalisib twice daily until disease progression or unacceptable toxicity.

Drug: Idelalisib

Interventions

Idelalisib DRUG

Idelalisib tablets or capsules administered orally

Also known as: Zydelig®, GS-1101, CAL-101

Idelalisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (18)

Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

UCLA

Los Angeles, California, 90095-1678, United States

Location

Stanford Cancer Center

Palo Alto, California, 94304-5548, United States

Location

Center for Cancer & Blood Disorders, PC

Bethesda, Maryland, 20817, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Long Island Jewish medical Center

New Hyde Park, New York, 11042, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Medical College of Cornell

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Willamette Valley Cancer Institute and Research Center

Springfield, Oregon, 97477, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer and Research Center

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Yakima Regional Cancer Care

Yakima, Washington, 98902, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792-5156, United States

Location

Related Publications (29)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• Benson 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.

  RESULT

• Brown 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.

  RESULT

• Brown 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.

  PMID: 24615777 RESULT

• Brown JR, Furman RR, et al. (2013). Final Results of a Phase 1 Study of Idelalisib (GS-1101) a Selective Inhibitor of Phosphatidylinositol 3-Kinase p110 Delta (PI3Kδ) in Patients with Relapsed or Refractory CLL [Presentation]. ASCO Annual Meeting, Chicago, Illinois.

  RESULT

• Coutre SE, Flinn IW, de Vos S, Barrientos JC, Schreeder MT, Wagner-Johnson ND, Sharman JP, Boyd TE, Fowler N, Dreiling L, Kim Y, Mitra S, Rai K, Leonard JP, Furman RR. Idelalisib in Combination With Rituximab or Bendamustine or Both in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia. Hemasphere. 2018 Apr 25;2(3):e39. doi: 10.1097/HS9.0000000000000039. eCollection 2018 Jun.

  PMID: 31723767 RESULT

• Coutre S, Barrientos C, et al. (2015). Safety of Idelalisib in B-cell Malignancies: Integrated Analysis of Eight Clinical Trials. ASCO Annual Meeting, Chicago, Illinois.

  RESULT

• Coutre S, Leonard J, et al. (2015). Idelalisib Monotherapy Results in Durable Responses in Patients with Relapsed or Refractory Waldenstrom's Macroglobulinemia. ASCO Annual Meeting, Chicago, Illinois.

  RESULT

• DeVos S, Wagner-Johnston ND, et al. (2014). Durable Responses Following Treatment with the PI3K-Delta Inhibitor Idelalisib in Combination with Rituximab, Bendamustine, or Both, in Recurrent Indolent non-Hodgkin Lymphoma: Phase I/II Results [Abstract 3063]. 56th ASH Annual Meeting and Exposition, San Francisco, California.

  RESULT

• DeVos S, Furman RR, et al. (2013). Idelalisib, a Selective Inhibitor of PI3Kδ, in Combination with Bendamustine, Fludarabine, or Chlorambucil in Patients with Relapsed or Refractory (R/R) CLL [Poster 2878]. 55th ASH Annual Meeting and Exposition, New Orleans, Louisiana.

  RESULT

• Flinn IW, Kahl BS, Leonard JP, Furman RR, Brown JR, Byrd JC, Wagner-Johnston ND, Coutre SE, Benson DM, Peterman S, Cho Y, Webb HK, Johnson DM, Yu AS, Ulrich RG, Godfrey WR, Miller LL, Spurgeon SE. Idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase-delta, as therapy for previously treated indolent non-Hodgkin lymphoma. Blood. 2014 May 29;123(22):3406-13. doi: 10.1182/blood-2013-11-538546. Epub 2014 Mar 10.

  PMID: 24615776 RESULT

• Furman R, DeVos S, et al. (2014). Long-Term Follow-Up of a Phase 1 Study of Idelalisib (ZYDELIG®) in Combination with Anti-CD20 Antibodies (Rituximab or Ofatumumab) in Patients with Relapsed or Refractory CLL. 56th ASH Annual Meeting and Exposition, San Francisco, California.

  RESULT

• Furman R, Sharman J, et al. (2013). A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib and Rituximab for Previously Treated Patients with CLL [Abstract LBA-6]. 55th ASH Annual Meeting and Exposition, New Orleans, Louisiana.

  RESULT

• Ghia P, Cheson BD, et al. (2016). Patterns of Idelalisib Treatment-Emergent Lymphocytosis in Patients with CLL or SLL [poster]. EHA 21st Congress, Copenhagen, Denmark.

  RESULT

• Ghia P, Coutre S, et al. (2016). Management of Transaminase Elevations Associated with Idelalisib [poster]. European Hematology Association (EHA) 21st Congress, Copenhagen, Denmark.

  RESULT

• Gopal AK, Davies AJ, et al. (2015). Idelalisib Monotherapy and Durable Responses in Patients with Relapsed or Refractory SLL. 57th ASH Annual Meeting and Exposition, Orlando, Florida.

  RESULT

• Kahl BS, Spurgeon SE, Furman RR, Flinn IW, Coutre SE, Brown JR, Benson DM, Byrd JC, Peterman S, Cho Y, Yu A, Godfrey WR, Wagner-Johnston ND. A phase 1 study of the PI3Kdelta inhibitor idelalisib in patients with relapsed/refractory mantle cell lymphoma (MCL). Blood. 2014 May 29;123(22):3398-405. doi: 10.1182/blood-2013-11-537555. Epub 2014 Mar 10.

  PMID: 24615778 RESULT

• Leonard JP, Wagner-Johnston ND, et al. (2013). Combinations of the PI3Kδ Inhibitor Idelalisib (GS-1101) with Rituximab and/or Bendamustine are Tolerable and Highly Active in Patients with Previously Treated, Indolent non-Hodgkin Lymphoma: Updated Results from a Phase I Study [Presentation]. ASCO Annual Meeting, Chicago, Illinois.

  RESULT

• Martin P, Armas A, et al. (2015). Idelalisib Monotherapy and Durable Responses in Patients with Relapsed or Refractory Marginal Zone Lymphoma (MZL). 57th ASH Annual Meeting and Exposition, Orlando, Florida.

  RESULT

• O'Brien SM, Lamanna N, Kipps TJ, Flinn I, Zelenetz AD, Burger JA, Keating M, Mitra S, Holes L, Yu AS, Johnson DM, Miller LL, Kim Y, Dansey RD, Dubowy RL, Coutre SE. A phase 2 study of idelalisib plus rituximab in treatment-naive older patients with chronic lymphocytic leukemia. Blood. 2015 Dec 17;126(25):2686-94. doi: 10.1182/blood-2015-03-630947. Epub 2015 Oct 15.

  PMID: 26472751 RESULT

• O'Brien SM, Lamanna N, et al. (2014). Update on a Phase 2 Study of Idelalisib in Combination with Rituximab in Treatment-Naive Patients ≥ 65 Years with CLL or SLL [Poster 1994]. 56th ASH Annual Meeting and Exposition, San Francisco, California.

  RESULT

• O'Brien SM, Lamanna N, et al. (2013). A Phase 2 Study of the Selective Phosphatidylinositol 3-Kinase Delta (PI3Kδ) Inhibitor Idelalisib (GS-1101) in Combination with Rituximab in Treatment-Naive Patients ≥ 65 Years with CLL or SLL [Presentation]. ASCO Annual Meeting, Chicago, Illinois.

  RESULT

• Spurgeon SE, Wagner-Johnston ND, et al. (2013). Final Results of a Phase 1 Study of Idelalisib, a Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ (PI3Kδ) in Patients with Relapsed or Refractory Mantle Cell Lymphoma [Presentation]. ASCO Annual Meeting, Chicago, Illinois.

  RESULT

• Wagner-Johnston ND, DeVos S, et al. (2013). Preliminary Results of PI3Kδ Inhibitor Idelalisib (GS-1101) Treatment in Combination with Everolimus, Bortezomib, or Bendamustine/Rituximab in Patients with Previously Treated Mantle Cell Lymphoma [Presentation]. ASCO Annual Meeting, Chicago, Illinois.

  RESULT

• Wierda W, Coutre S, et al. (2016). Management of Transaminase Elevations in Patients Receiving Idelalisib. ASCO Annual Meeting, Chicago, Illinois.

  RESULT

• de Vos S, Wagner-Johnston ND, Coutre SE, Flinn IW, Schreeder MT, Fowler NH, Sharman JP, Boccia RV, Barrientos JC, Rai KR, Boyd TE, Furman RR, Kim Y, Godfrey WR, Leonard JP. Combinations of idelalisib with rituximab and/or bendamustine in patients with recurrent indolent non-Hodgkin lymphoma. Blood Adv. 2016 Nov 30;1(2):122-131. doi: 10.1182/bloodadvances.2016000976. eCollection 2016 Dec 13.

  PMID: 29296805 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin

Interventions

idelalisib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 22, 2010
• Study Start: March 22, 2010
• Primary Completion: June 18, 2018
• Study Completion: June 18, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (18)