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A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination With Irinotecan Versus Cetuximab and Irinotecan for Patients With Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels


Phase 2
18 Years
N/A
Not Enrolling
Both
Rectal Neoplasms

Thank you

Trial Information

A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination With Irinotecan Versus Cetuximab and Irinotecan for Patients With Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Time Frame:

From randomization (Cycle 1 Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to approximately 3 years)

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

0646-025

NCT ID:

NCT01609231

Start Date:

July 2012

Completion Date:

September 2015

Related Keywords:

  • Rectal Neoplasms
  • Neoplasms
  • Rectal Neoplasms

Name

Location

Call for Information (Investigational Site 0015) Wichita, Kansas  67214
Call for Information (Investigational Site 0044) Los Angeles, California  90033
Call for Information (Investigational Site 0012) New Brunswick, New Jersey  08901
Call for Information (Investigational Site 0011) Chapel Hill, North Carolina  27514
Call for Information (Investigational Site 0016) Nashville, Tennessee  37232