Status:
COMPLETED
Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
Lead Sponsor:
Amgen
Conditions:
Colon Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoint...
Eligibility Criteria
Inclusion
- Diagnosis of metastatic adenocarcinoma of the colon or rectum
- Available paraffin-embedded tumor tissue
- Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
- Measurable disease
- Adequate hematologic, renal, hepatic and metabolic function
Exclusion
- Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
- Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
- Prior irinotecan therapy, anti epidermal growth factor receptor (EGFr) therapy, or vaccine for the treatment of mCRC
- CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
- Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1
- Clinically significant cardiovascular disease
- History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
- Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to Day 1 of Cycle 1
- Any significant bleeding ≤ 6 weeks prior to Day 1 of Cycle 1, per the investigator's judgement
- Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
- Any co-morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
- Major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤ 4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery and have no significant complications
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00411450
Start Date
November 1 2006
End Date
October 1 2010
Last Update
February 15 2016
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