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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025)

NCTNCT01609231 (opens ClinicalTrials.gov in a new tab)Other id0646-025Other id2012-000317-36Other idMK-0646-025
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures IGF-1 (mecasermin), does not give it. It appears in the eligibility rules.

Overview

Status
Terminated
Phase
Phase 2
Enrollment
11 participants (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
6 Jul 2012
Primary completion
9 Dec 2014
Completion
9 Dec 2014
First posted
31 May 2012 (estimated)
Last update posted
4 May 2020
Conditions
Rectal Neoplasms

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 2

    A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025)

    NCT01609231

    6 Jul 2012 to 9 Dec 2014

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this adaptive trial is to compare the progression-free survival of participants with metastatic rectal carcinoma when treated with intravenous (IV) dalotuzumab (MK-0646) + irinotecan therapy relative to participants treated with IV cetuximab + irinotecan. The primary hypothesis is that administration of dalotuzumab in combination with irinotecan to participants with wild-type KRAS metastatic rectal carcinoma with high insulin growth factor (IGF)-1/low IGF-2 expression levels improves progression-free survival compared to patients treated with cetuximab in combination with irinotecan.

Interventions

  • DalotuzumabDrug
  • IrinotecanDrug
  • CetuximabDrug

Arms2

  • Experimental

    Arm A: Dalotuzumab + Irinotecan

    Participants receive irinotecan intravenously (IV), 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).

  • Active comparator

    Arm B: Cetuximab + Irinotecan

    Participants receive cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Assessment of Progression-free Survival (PFS)

    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 3 years)

    Registry description

    PFS is a measure of the time from randomization to the time of first documented disease progression (assessed by an independent Radiology Review Committee \[iRRC\]) or participant death, whichever occurs first.

Secondary outcomes(1)

  1. Percentage of Participants With Objective Response Rate (ORR)

    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 3 years)

    Registry description

    ORR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) during the course of the study using enhanced Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Confirmation of response was not required.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Assessment of Progression-free Survival (PFS)

GroupValue
Dalotuzumab + Irinotecannot posted
Cetuximab + Irinotecannot posted
Secondary and other outcome results(1)
Secondary outcome· From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years)

Percentage of Participants With Objective Response Rate (ORR)

GroupValue
Dalotuzumab + Irinotecannot posted
Cetuximab + Irinotecannot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Dalotuzumab + IrinotecanParticipants received irinotecan IV, 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).1 / 61 / 66 / 6
Cetuximab + IrinotecanParticipants received cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).2 / 54 / 55 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Has metastatic colorectal cancer with primary tumor originating from the rectum * Has an available archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies * Has 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 * Has a performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale Exclusion Criteria: * Has poorly-controlled diabetes * Has received 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 * Has received radiotherapy within 2 weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain * Is 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 * Was unable to complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (\>4 months exposure) * Has prior exposure to insulin-like growth factor 1 receptor (IGF-1R) inhibitors or epidermal growth factor receptor (EGFR) inhibitors * Has a known central nervous system (CNS) metastases and/or carcinomatous meningitis * Has primary CNS tumor * Has a 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. * Is human immunodeficiency virus (HIV)-positive * Has active hepatitis B or C infection and is receiving antiviral treatment regimens * Has symptomatic ascites or pleural effusion * Is concurrently using growth hormone (GH), or growth hormone inhibitors

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