Clinical Trial Detail

The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with dalotuzumab + irinotecan therapy relative to participants treated with cetuximab + irinotecan.

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Metastatic colorectal cancer with primary tumor originating from the rectum

- Available archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies

- At least one measurable lesion greater than or equal to 10 mm

- Disease has progressed after treatment with both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy

- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale

Other eligibility criteria may apply.

- Known diabetic who is poorly controlled

- Chemotherapy or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery

- Radiotherapy within 2 weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain

- Currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study

- Could not complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (>4 months exposure)

- Prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors

- Known Central Nervous System (CNS) metastases and/or carcinomatous meningitis

- Primary CNS tumor

- History of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma; potentially curative therapy with no evidence of that disease for 5 years, deemed low risk for recurrence by treating physician.

- Human Immunodeficiency Virus (HIV)-positive

- Active Hepatitis B or C receiving antiviral treatment regimens

- Symptomatic ascites or pleural effusion

- Concurrently using growth hormone (GH), or growth hormone inhibitors

Other exclusion criteria may apply.