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).

• Register: EUCTR
• Last refreshed on: 7 January 2019
• Main ID: EUCTR2011-006293-72-IT
• Date of registration: 19/06/2012
• Prospective Registration: Yes
• Primary sponsor: GILEAD SCIENCES INC.
• Public title: 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).
• Scientific 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. A Companion Trial to Study GS-US-312-0116: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL 101) in Combination with Rituximab as Therapy for Patients with Previously Treated Chronic Lymphocytic Leukemia.
• Date of first enrolment: 01/08/2012
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006293-72
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: yes; Other specify the comparator: - same IMP used at different dosage; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Italy, United Kingdom, United States

Contacts

• Name: Medical Monitor
• Affiliation: Gilead Sciences Inc.

• Name: Medical Monitor
• Affiliation: Gilead Sciences Inc.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic lymphocytic leukemia (CLL)
MedDRA version: 14.1 Level: PT Classification code 10008958 Term: Chronic lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: 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]

Intervention(s)

Product Name: NA
Product Code: GS-1101
Pharmaceutical Form: Tablet
CAS Number: 870281-82-6
Current Sponsor code: GS-1101
Other descriptive name: CAL-101
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: NA
Product Code: GS-1101
Pharmaceutical Form: Tablet
CAS Number: 870281-82-6
Current Sponsor code: GS-1101
Other descriptive name: CAL-101
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Every 8-12 weeks.

Secondary Objective: Determining the effect of GS-1101 on the onset, magnitude, and duration of tumor control; overall survival (OS); health-related quality of life (HRQL); changes in subject performance status; disease-associated biomarkers and potential mechanisms of resistance; safety; health resource utilization.

Primary end point(s): Progression-free survival (PFS); Overall response rate (ORR); Time to response (TTR); Duration of response (DOR); Time to treatment failure (TTF).

Main Objective: -To determine the effect of GS-1101 on the onset, magnitude, and duration of tumor control; -To compare tumor control in subjects receiving rituximab alone in Study GS-US-312-0116 to that observed in the same subjects when receiving the standard dose of GS-1101 alone in Study GS-US- 312-0117; -To assess the effect of GS-1101 on measures of subject well-being, including overall survival (OS), health related quality of life (HRQL), and performance status; -To assess the effects of GS-1101 on disease associated biomarkers and to evaluate potential mechanisms of resistance to GS-1101; -To characterize exposure to GS-1101 as determined by treatment administration and evaluation of GS-1101 plasma concentrations over time; - To describe the safety profile observed with GS-1101; - To estimate health resource utilisation.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Every 8-12 weeks.

Secondary end point(s): Percent change in lymph node area; Lymph node response rate; Splenomegaly response rate; Hepatomegaly response rate; Platelet response rate; Hemoglobin response rate; Neutrophil response rate.

Secondary ID(s)

GS-US-312-0117

2011-006293-72-GB

Source(s) of Monetary Support

Gilead Sciences Inc.