A Phase 3, Double-Blind Extension Study of GS-1101 at Different Dose Levels for Previously Treated CLL patients (a Companion Trial to GS-US-312-0116).

Phase 1

• Conditions: Chronic lymphocytic leukemia (CLL); MedDRA version: 14.1Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-006293-72-IT
• Lead Sponsor: GILEAD SCIENCES INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-19
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

-Participation in Study GS-US-312-0116; - Occurrence of confirmed, definitive CLL progression while receiving study drug therapy (GS 1101/placebo) in Study GS US 312 0116. Note: Definitive disease progression is CLL progression based on standard criteria and occurring for any reason (ie, increasing lymphadenopathy, organomegaly, or bone marrow involvement; decreasing platelet count, hemoglobin, or neutrophil count; or worsening of disease-related symptoms) other than lymphocytosis. Subjects must have confirmation by the sponsor working in collaboration with an independent review committee (IRC) that the disease has progressed on the clinical trial (Study GS-US-312-0116) before receiving secondary GS 1101 therapy on this extension trial (Study GS-US-312-0117); -Presence of radiographically measurable lymphadenopathy (defined as the presence of =1 nodal lesion that measures =2.0 cm in the longest dimension [LD] and =1.0 cm in the longest perpendicular dimension [LPD] as assessed by CT or MRI); -Permanent cessation of Study GS-US-312-0116 treatment (rituximab and GS-1101/placebo) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, systemic corticosteroids, or investigational therapy) for the treatment of CLL; -The time from permanent cessation of Study GS-US-312-0116 treatment (rituximab and/or GS-1101/placebo) and the initiation of Study GS-US-312-0117 therapy is =12 weeks. Note: Study procedures performed as part of Study GS-US-312-0116 need not be repeated and can be used as screening procedures for Study GS-US-312-0117 if performed within 4 weeks prior to initiation of study drug therapy on Study GS-US-312-0117; -Karnofsky performance score of =40; -Required baseline laboratory data (within 4 weeks prior to initiation of study treatment).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation); Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of the start of study treatment (Visit 2). Note: Subjects with localized fungal infections of skin or nails are eligible. Subjects may be receiving prophylactic antiviral or antibacterial therapies at the discretion of the investigator; anti-pneumocystis prophylaxis is encouraged; Pregnancy or breastfeeding; Intentional breaking of the blind in Study GS-US-312-0116 by the investigator or the study subject; Concurrent participation in another therapeutic clinical trial; -Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified