A Study to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With HER2-Positive Metastatic or Locally Advanced Inoperable Cancer

Genentech

Status and phase: Completed; Phase 1

Conditions: Solid Cancers

Treatments: Drug: carboplatin; Drug: trastuzumab; Drug: docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00927589

GO01305 (Other Identifier)

H4613g

Details and patient eligibility

About

This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin pharmacokinetics in patients with HER2-positive metastatic or locally advanced inoperable cancer.

The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia's correction; the QTcB interval is the QT interval as calculated using Bazett's correction.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic documentation of a HER2-positive solid malignancy in patients with metastatic or locally advanced inoperable disease
• Left ventricular ejection fraction (LVEF) >/= 50% by multiple-gated acquisition (MUGA) scan or two-dimensional echocardiography (ECHO) </= 42 days prior to Cycle 1, Day 1

Exclusion criteria

• History of trastuzumab treatment </= 100 days prior to Cycle 1, Day 1
• Pretreatment QTcF interval > 450 ms as determined by local assessment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

1

Experimental group

Treatment:

Drug: trastuzumab

Drug: docetaxel

Drug: carboplatin