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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.

AbstractBACKGROUND:
This phase 2 study evaluated trebananib (AMG 386), an investigational peptide-Fc fusion protein that neutralises the interaction between angiopoietins-1/2 and the Tie2 receptor, plus FOLFIRI as second-line treatment for patients with metastatic colorectal cancer.
METHODS:
Patients had adenocarcinoma of the colon or rectum with progression within 6 months of receiving only one prior fluoropyrimidine/oxaliplatin-based chemotherapy regimen for metastatic disease. All patients received FOLFIRI and were randomised 2:1 to also receive intravenous trebananib 10 mg kg(-1) once weekly (QW) (Arm A) or placebo QW (Arm B). The primary end point was investigator-assessed progression-free survival (PFS).
RESULTS:
One hundred and forty-four patients were randomised (Arms A/B, n=95/49). Median PFS in Arms A and B was 3.5 and 5.2 months (hazard ratio (HR) 1.23; 95% CI, 0.81-1.86; P=0.33) and median overall survival (OS) was 11.9 and 8.8 months, respectively (HR 0.90; 95% CI; 0.53-1.54; P=0.70). Objective response rate (ORR) was 14% and 0% in Arms A and B, respectively. Incidence of grade ≥3 adverse events was similar between treatment arms (Arm A, 61%; Arm B, 65%) and included pulmonary embolism (1%/4%), deep vein thrombosis (5%/2%), and hypertension (1%/0%).
CONCLUSION:
Administration of trebananib plus FOLFIRI did not prolong PFS compared with placebo plus FOLFIRI. Toxicities were manageable and consistent with those known for FOLFIRI and trebananib.
AuthorsM Peeters, A H Strickland, M Lichinitser, A V S Suresh, G Manikhas, J Shapiro, W Rogowski, X Huang, B Wu, D Warner, R Jain, N C Tebbutt
JournalBritish journal of cancer (Br J Cancer) Vol. 108 Issue 3 Pg. 503-11 (Feb 19 2013) ISSN: 1532-1827 [Electronic] England
PMID23361051 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Biomarkers, Tumor
  • Recombinant Fusion Proteins
  • Leucovorin
  • Fluorouracil
  • trebananib
  • Camptothecin
Topics
  • Adenocarcinoma (drug therapy, mortality, secondary)
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Biomarkers, Tumor (analysis)
  • Camptothecin (administration & dosage)
  • Colorectal Neoplasms (drug therapy, mortality, pathology)
  • Double-Blind Method
  • Female
  • Fluorouracil (administration & dosage)
  • Humans
  • International Agencies
  • Leucovorin (administration & dosage)
  • Liver Neoplasms (drug therapy, mortality, secondary)
  • Male
  • Middle Aged
  • Prognosis
  • Recombinant Fusion Proteins (administration & dosage)
  • Salvage Therapy
  • Survival Rate
  • Young Adult

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