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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00752570
First Posted: September 15, 2008
Last Update Posted: September 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
September 11, 2008
September 15, 2008
September 2, 2015
November 2008
September 2010   (Final data collection date for primary outcome measure)
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). ]
Same as current
Complete list of historical versions of study NCT00752570 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate progression free survival and measures of efficacy by KRAS status [ Time Frame: Treatment phase ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Cancer
  • Carcinoma
  • Colon Cancer
  • Colorectal Cancer
  • Gastrointestinal Cancer
  • Metastases
  • Metastatic Cancer
  • Metastatic Colorectal Cancer
  • Oncology
  • Rectal Cancer
  • 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.
  • Drug: FOLFIRI

    Administration of FOLFIRI chemotherapy will commence on day 1 of each dosing week following the administration of AMG 386.

    FOLFIRI Q2W regimen: irinotecan 180 mg/m2 IV over 90 (+-15) minutes on Day 1, leucovorin 400 mg/m2 IV over 2 hrs on Day 1, 5 FU 400mg/m2 IV bolus, followed by 2400 mg/m2 continuous IV infusion over 46 hrs +- 2 hours.

    FOLFIRI will be administered until disease progression, FOLFIRI intolerability, death, or study withdrawal by the subject, investigator, or sponsor, whichever occurs earliest.

  • Placebo Comparator: 2
    AMG 386 placebo QW, FOLFIRI Q2W
    Interventions:
    • Drug: AMG 386 Placebo
    • Drug: FOLFIRI
  • Active Comparator: 1
    Arm 1 : AMG 386 10 mg/kg QW, FOLFIRI Q2W
    Interventions:
    • Drug: AMG 386
    • Drug: FOLFIRI
Peeters M, Strickland AH, Lichinitser M, Suresh AV, Manikhas G, Shapiro J, Rogowski W, Huang X, Wu B, Warner D, Jain R, Tebbutt NC. A randomised, double-blind, placebo-controlled phase 2 study of trebananib (AMG 386) in combination with FOLFIRI in patients with previously treated metastatic colorectal carcinoma. Br J Cancer. 2013 Feb 19;108(3):503-11. doi: 10.1038/bjc.2012.594. Epub 2013 Jan 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
June 2012
September 2010   (Final data collection date for primary outcome measure)

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])
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Belgium,   France,   India,   Ireland,   Poland,   Russian Federation,   United States
 
NCT00752570
20070307
Not Provided
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP