0117 - Phase 3 Extension Study of GS-1101 in CLL

• Research type

  Research Study

• Full title

  A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent GS 1101 (CAL 101) as Therapy for Patients with Previously Treated Chronic Lymphocytic Leukemia

• IRAS ID

  102439

• Contact name

  Peter Hillmen

• Sponsor organisation

  Gilead Sciences Inc.

• Eudract number

  2011-006293-72

• ISRCTN Number

  n/a

• Research summary

  Chronic Lymphocytic Leukaemia is a serious and potentially life-threatening cancer primarily of older people. Standard treatment consists of rituximab often with other chemotherapy drugs. Rituximab is usually well tolerated (side effects tend to be mild), but the companion chemotherapy is often too toxic or less effective for older patients or those with co-existing medical conditions. This study is being done to test a new medicine called GS-1101, which is hoped will be an effective, well tolerated option for patients unable to receive chemotherapy. So far GS-1101 has only been given to patients or healthy individuals in other clinical trials; it has been considered safe and well tolerated. This clinical trial (Study GS-US-312-0117) is a separate, multicentre, 2-arm, double-blind, parallel-group extension study that is a companion study to the primary study (GS-US-312-0116). Compliant participants who are tolerating therapy but who develop definitive disease progression in the primary clinical trial can consider enrollment in this separate companion extension trial. In the extension trial, participants will take active blinded GS-1101 therapy, either at a higher starting dose or at the standard starting dose, with allocation based on the original primary study randomization. Participants will be assigned to either of the following treatment assignments with allocation based on the original primary study randomization: ú Arm A: GS-1101 (300 mg BID) ú Arm B: GS-1101 (150 mg BID) GS-1101 will be taken orally, twice daily, continuously. Participants will continue in the study until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable study drug-related toxicity, pregnancy, substantial noncompliance with study procedures, or study discontinuation. Study visits will be fortnightly for 12 weeks, then 4 weekly until Week 24, every 6 weeks to Week 48 then every 12 weeks. Study visits will include blood tests, physical examinations and questionnaires. There will be CT or MRI scans at Weeks 8, 16, 24, 36 and 48, every 12 weeks up to Week 96 and then at the end of treatment. This study is sponsored by Gilead, 160 subjects will participate worldwide.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0179

• Date of REC Opinion

  8 May 2012

• REC opinion

  Favourable Opinion