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A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)

NCT01702558 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2021-01-22

Study results available
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Summary

This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.

Conditions

Interventions

DRUG

Capecitabine

Capecitabine will be administered at de-escalating doses (starting from 750 mg/m\^2) to determine the MTD.

DRUG

Trastuzumab emtansine (T-DM1)

Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg via IV infusion every 3 weeks.

DRUG

Trastuzumab emtansine (T-DM1)

Trastuzumab emtansine will be administered at a dose of 2.4 mg/kg via IV infusion every week.

DRUG

Capecitabine

Capecitabine will be administered at the MTD determined in Cohort 1.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-03
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Argentina
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Portugal
  • Russia
  • Serbia
  • Slovakia
  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01702558 on ClinicalTrials.gov