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NCT01652482 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)

A Phase 2 study of Colorectal Cancer, sponsored by Genentech.

Completed
Registry status
Phase 2
Development phase
135
Enrollment target
20
Study locations

NCT01652482 is a Phase 2 study of Colorectal Cancer that has completed, run by Genentech. The registered enrollment target is 135 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT01652482, a Phase 2 study of Colorectal Cancer, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 2
Development phase
135 participants
Enrollment target
20
Study locations

Study Summary

This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid \[leucovorin\], 5-fluorouracil \[5-FU\], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Conditions Studied

Interventions

  • DRUG Leucovorin
  • DRUG Cetuximab
  • DRUG Irinotecan
  • DRUG 5-fluorouracil
  • DRUG MEHD7945A

Study Locations (20)

California

  • - Bakersfield
  • - Fullerton
  • - Los Angeles
  • - Los Angeles
  • - San Luis Obispo
  • - Santa Barbara

Massachusetts

  • - Boston
  • - Boston

Washington

  • - Kirkland
  • - Seattle

Colorado

  • - Aurora

Florida

  • - Orange Park

Illinois

  • - Harvey

Kentucky

  • - Paducah

Maryland

  • - Rockville

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2012-10
Est. Completion 2014-11
Phase Phase 2

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT01652482

The ClinicalTrials.gov registry entry for NCT01652482 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Leucovorin is the first listed.

NCT01652482 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Massachusetts, Washington.

Frequently Asked Questions

What is clinical trial NCT01652482 about?

NCT01652482 is a clinical study titled "Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)". This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid \[leucovorin\], 5-fluorouracil \[5-FU\], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Vir...

What is the current status of trial NCT01652482?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2012-10. Estimated completion is 2014-11.

What conditions does trial NCT01652482 study?

This clinical trial studies the following conditions: Colorectal Cancer.

What interventions are being tested in trial NCT01652482?

The interventions under investigation include: Leucovorin (DRUG), Cetuximab (DRUG), Irinotecan (DRUG), 5-fluorouracil (DRUG), MEHD7945A (DRUG).

Who is sponsoring clinical trial NCT01652482?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01652482 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.