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A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma

Tracking Information

Start Date ^ICMJE	November 2008
Estimated Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 12, 2008)	To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo. [ Time Frame: The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death). ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00752570 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 12, 2008)	To evaluate other measures of efficacy or clinical response including objective response rate (ORR), duration of response (DOR), overall survival (OS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo [ Time Frame: Treatment phase or until disease progression ] [ Designated as safety issue: Yes ] To evaluate progression free survival and measures of efficacy by KRAS status [ Time Frame: Treatment phase ] [ Designated as safety issue: No ] To evaluate patient reported outcomes (PROs), relative dose intensity, incidence of anti AMG 386 antibody formation, pharmacokinetics of AMG 386 (Cmax and AUC) and safety (incidence of AEs and significant laboratory changes) [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information

Brief Title ^ICMJE	A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
Official Title ^ICMJE	A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
Brief Summary	This clinical trial will compare the efficacy and safety of the combination of AMG 386 and FOLFIRI with FOLFIRI alone in second line treatment of metastatic colorectal cancer.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Cancer Carcinoma Colon Cancer Colorectal Cancer Gastric Cancer Gastrointestinal Cancer Metastases Metastatic Cancer Metastatic Colorectal Cancer Oncology Rectal Cancer
Intervention ^ICMJE	Drug: AMG 386 AMG 386 (10 mg/kg QW) will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent. Drug: AMG 386 Placebo AMG 386 placebo QW will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.
Study Arms / Comparison Groups	2: Placebo Comparator AMG 386 placebo QW, FOLFIRI Q2W Intervention: Drug: AMG 386 Placebo 1: Active Comparator Arm 1 : AMG 386 10 mg/kg QW, FOLFIRI Q2W Intervention: Drug: AMG 386

Recruitment Information

Estimated Enrollment ^ICMJE

138

Estimated Completion Date

February 2013

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
One and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. Prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted
At least one uni dimensionally measurable lesion per modified RECIST criteria. All sites of disease must be evaluated <= 28 days before randomization
Radiographically documented disease progression per modified RECIST criteria either while receiving or <= 6 months after the last dose of prior chemotherapy regimen for metastatic disease
ECOG performance status of 0 or 1
Man or woman >= 18 years of age
Adequate end organ assessments by laboratory studies (hematological and chemistries)
Life expectancy >= 3 months

Exclusion Criteria:

Exclude subjects with a history of prior malignancy, except:
- Malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by treating physician
- Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
Prior irinotecan therapy
Systemic chemotherapy, hormonal therapy, or immunotherapy <= 21 days prior to randomization
Experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days prior to randomization
Clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
Known allergy or hypersensitivity to irinotecan, 5 FU (known dihydropyrimidine dehydrogenase deficiency) or leucovorin
Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= CTC grade 2 [CTCAE version 3.0])

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Amgen Call Center

866-572-6436

Location Countries ^ICMJE

United States, Australia, Belgium, France, India, Ireland, Poland, Russian Federation

Administrative Information

NCT ID ^ICMJE

NCT00752570

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20070307

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Source: http://clinicaltrials.gov/