Efficacy and Safety of GS-6624 With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma - Full Text View

Purpose

This randomized study compares the efficacy of GS-6624 versus placebo in combination with FOLFIRI in subjects with colorectal cancer.

Condition	Intervention	Phase
Colorectal Cancer	Drug: GS-6624 Drug: FOLFIRI Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	265
Study Start Date:	November 2011
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 700 mg GS-6624 and FOLFIRI (open-label) Open-label, 28-day treatment period performed to assess the safety and tolerability of GS-6624 dosed at 700 mg followed by intravenous (IV) FOLFIRI.	Drug: GS-6624 700 mg dosed biweekly Drug: FOLFIRI dosed biweekly.
Experimental: 200 mg GS-6624 and FORFIRI (randomized) Randomized, double blind, placebo-controlled portion; subjects will be randomized to 200, mg GS-6624, 700 mg GS-6624, or placebo followed by FOLFIRI.	Drug: GS-6624 200 mg dosed biweekly Drug: FOLFIRI dosed biweekly
Experimental: 700 mg GS-6624 and FOLFIRI (randomized) Randomized, double- blinded, placebo-controlled portion of the trial for subjects randomized to 200 mg GS-6624, 700 mg GS-6624, or placebo in combination with intravenous (IV) FOLFIRI.	Drug: GS-6624 700 mg dosed biweekly Drug: FOLFIRI dosed biweekly
Experimental: Placebo and FOLFIRI (randomized) Randomized, double- blinded, placebo-controlled portion of the trial for subjects randomized to 200 mg GS-6624, 700 mg GS-6624, or placebo in combination with intravenous (IV) FOLFIRI.	Drug: Placebo dosed biweekly Drug: FOLFIRI dosed biweekly

Detailed Description:

This randomized Phase 2 study compares the additive efficacy of GS-6624 versus placebo in combination with FOLFIRI in subjects with metastatic KRAS or BRAF mutant colorectal cancer.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Metastatic Colorectal Carcinoma with KRAS mutation.
Received first line therapy and discontinued part or all of first line therapy.
Estimated life expectancy > 3 months.
Stage IV disease.
ECOG 0-2.
Adequate hepatic and hematologic function
No major operations within 4 weeks prior to treatment start.

Exclusion Criteria:

More than 1 prior chemotherapy regimen for stage 4 colorectal cancer.
Experimental medical treatment within 30 days prior to study entry.
Known or suspected cerebral metastases.
History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment.
Known dihydropyrimidine dehydrogenase-deficiency (special screening not required).
Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or ECG abnormalities consistent with ischemia.
Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at Screening.
Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis.
Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
Prior irinotecan therapy for metastatic disease is not permitted.
Systemic fungal, bacterial, viral, or other infection.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479465

Contacts

Contact: Claudia Lee		Claudia.Lee@gilead.com
Contact: Zung Thai, M.D.		Zung.Thai@gilead.com

Show 108 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Mike Hawkins, M.D.

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01479465 History of Changes
Other Study ID Numbers:	GS-US-295-0203
Study First Received:	November 9, 2011
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

GSI
Gilead
Gilead Sciences
GS-6624

Colorectal Cancer
KRAS
Oncology
monoclonal antibody

Additional relevant MeSH terms:

Adenocarcinoma
Adenocarcinoma, Mucinous
Colorectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Intestinal Neoplasms

Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013