Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 February 2015 |
Main ID: |
EUCTR2011-003754-61-ES |
Date of registration:
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12/04/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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This is a clinical research study involving an experimental drug named GS-6624 for the treatment of metastatic colorectal adenocarcinoma, a sub-type of cancer of the colon and/or rectum.
The purpose of this study is to test the effectiveness and safety of GS-6624 at different dose levels when it is given with FOLFIRI. We want to find out what effects, good and/or bad, GS-6624 has on you and your metastatic colorectal adenocarcinoma when it is given with FOLFIRI.
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Scientific title:
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled
Study to Evaluate the Efficacy and Safety of GS-6624
Combined with FOLFIRI as Second Line Treatment for
Metastatic KRAS Mutant Colorectal Adenocarcinoma
that Has Progressed Following a First Line Oxaliplatin- and
Fluoropyrimidine-Containing Regimen. |
Date of first enrolment:
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22/05/2012 |
Target sample size:
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265 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003754-61 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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France
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Germany
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Italy
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Poland
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Spain
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United States
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Contacts
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Name:
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Medical Monitor
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Address:
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333 Lakeside Drive
CA 94404
Foster City
United States |
Telephone:
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+1650522 4707 |
Email:
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Zung.Thai@gilead.com |
Affiliation:
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Gilead Sciences, Inc. |
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Name:
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Medical Monitor
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Address:
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333 Lakeside Drive
CA 94404
Foster City
United States |
Telephone:
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+1650522 4707 |
Email:
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Zung.Thai@gilead.com |
Affiliation:
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Gilead Sciences, Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. KRAS mutated, histologically confirmed adenocarcinoma of the colon or rectum. 2. The subject must have received first-line combination therapy containing oxaliplatin and a fluoropyrimidine with or without bevacizumab for metastatic disease and o Experienced radiographic disease progression during first-line therapy, or Experienced radiographic disease progression within 6 months after the last dose of first-line therapy, or Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression within 6 months after the last dose of first-line therapy; or Not be a candidate for therapy with additional oxaliplatin. 3. Stage IV disease. 4. ECOG 0-2. 5. Age ? 18 years. 6. Estimated life expectancy > 3 months. 7. Measurable disease per RECIST version 1.1, defined with all of following criteria: 1. Lesions accurately measured in at least 1 dimension 2. The longest diameter in the plane of measurement is to be recorded 3. A minimum size of 10 mm if CT slice thickness ? 5 mm; if thickness is > 5 mm then the minimum size of measurable lesions should be twice slice thickness. 8. Women of childbearing potential must agree to use one medically approved (ie, mechanical or pharmacological) contraceptive measure and have their partners agree to an additional barrier method of contraception for the duration of the study and for 90 days after the last administration of study drug. 9. Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation for the duration of this study and for 90 days after the last administration of study drug. 10. Adequate hematologic function: neutrophils ? 1.5 x 109/L, platelets ? 100 x 109/L, hemoglobin ? 9 g/dL. 11. Coagulation: International Normalized Ratio (INR) ? 1.6 (unless receiving anticoagulation therapy). Patients on fulldose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin. If receiving warfarin, the patient must have an INR ? 3.0 and no active bleeding (ie, no bleeding within 14 days prior to first dose of study therapy). 12. Adequate hepatic function: Direct or total bilirubin ? 1.5 x upper limit of normal (ULN). ALT and AST ? 2.5 x ULN, in case of liver metastases <= 5 x ULN. 13. Serum creatinine ? 1.5 x ULN. 14. No major operations within 4 weeks prior to treatment start. 15. No relevant toxicities due to prior medical treatment at time of study entry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 255 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria: 1. More than 1 prior chemotherapy regimen for stage 4 colorectal cancer. 2. Experimental medical treatment within 30 days prior to study entry. 3. Pregnant or breast feeding women (pregnancy needs to be excluded by testing of beta-HCG). 4. Known or suspected cerebral metastases. 5. Acute or subacute ileus, chronic inflammatory bowel disease, or chronic diarrhea. 6. Known dihydropyrimidine dehydrogenase-deficiency (special screening not required). 7. Known glucuronidation-deficiency (special screening not required). 8. Known alcohol or drug abuse or any other medical or psychiatric condition which contraindicates participation in the study. 9. History or presence of any form of cancer, other than colorectal cancer, within the 3 years prior to enrollment, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis. 10. Myocardial infarction within the last 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication. 11. Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis. 12. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics use. 13. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization. 14. Prior irinotecan therapy. 15. Known hypersensitivity to the study investigational medicinal products, formulation excipients, irinotecan, 5 FU, or leucovorin.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Metastatic KRAS Mutant Colorectal Adenocarcinoma MedDRA version: 14.1
Level: LLT
Classification code 10052360
Term: Colorectal adenocarcinoma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Product Code: GS-6624 Pharmaceutical Form: Solution for infusion Current Sponsor code: GS-6624 Other descriptive name: GS-6624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Progression free survival is the primary endpoint of the study and is measured as time from date of randomization to the earliest event time of a) death regardless of cause, or b) first indication of disease progression.
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Main Objective: To compare the additive efficacy of GS-6624 vs. placebo in combination with FOLFIRI as measured by improvement in progression free survival (PFS) in subjects with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first line oxaliplatin- and fluoropyrimidine-containing regimen.
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Primary end point(s): Progression free survival signs
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Secondary Objective: ? To compare the additive efficacy of GS-6624 vs. placebo in combination with FOLFIRI as measured by improvement in overall survival; ? To compare the additive efficacy of GS-6624 vs. placebo in combination with FOLFIRI as measured by improvement in objective response rate per RECIST (ver. 1.1); ? To compare the safety of GS-6624 vs. placebo in combination with FOLFIRI as measured by incidence of adverse events, infusion site reactions, clinical relevant changes in laboratory values, ECG, and vital signs.
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Secondary Outcome(s)
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Secondary end point(s): ? To compare the additive efficacy of GS-6624 vs. placebo in combination with FOLFIRI as measured by improvement in overall survival; ? To compare the additive efficacy of GS-6624 vs. placebo in combination with FOLFIRI as measured by improvement in objective response rate per RECIST (ver. 1.1); ? To compare the safety of GS-6624 vs. placebo in combination with FOLFIRI as measured by incidence of adverse events, infusion site reactions, clinical relevant changes in laboratory values, ECG, and vital signs.
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Timepoint(s) of evaluation of this end point: Overall survival is measured as time from date of randomization to death regardless of cause.
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Secondary ID(s)
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GS-US-295-0203
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Source(s) of Monetary Support
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Gilead Sciences, Inc.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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