Comparison of study drug Panitumumab With Supportive Care to Best Supportive Care in Patients With Metastatic Colorectal Cancer

Phase 3

Completed

• Conditions: Health Condition 1: C189- Malignant neoplasm of colon, unspecifiedHealth Condition 2: C20- Malignant neoplasm of rectumHealth Condition 3: null- Metastatic Colorectal Cancer

• Registration Number: CTRI/2012/03/002529
• Lead Sponsor: Amgen Technology Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-06-29
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 23

Inclusion Criteria

Inclusion Criteria:

Diagnosis of metastatic colorectal cancer

Wild type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory

ECOG performance status of 0, 1 or 2

At least 1 measurable or non measurable lesion per RECIST version 1.1 guidelines.

Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.

Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease

Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil uracil) at any point for treatment of CRC

Man or woman at least 18 years of age

Adequate hematologic, renal, hepatic and metabolic function

Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)

Subject or subjects legally acceptable representative has provided informed consent.

Other protocol specified criteria may apply

Exclusion Criteria

Exclusion Criteria:

Symptomatic brain metastases requiring treatment

History of another primary cancer within 5 years of randomization

Prior anti-EGFR antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib)

Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization

Radiotherapy within 14 days before randomization.

Exclusion Criteria for QTc Evaluation Subpart of the Study: Prolongation of QT/QTc interval 450 milliseconds at screening

Other protocol-specified criteria may apply

Study & Design

• Study Type: Interventional
• Study Design: Not specified