CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3 enrolled
Drug / intervention
Pertuzumabdrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Completed treatment in a prior Genentech-sponsored Phase II pertuzumab cancer study with at least one dose received
  • ✓Enrollment within 3 months of last pertuzumab dose from parent study
  • ✓ECOG performance status 0, 1, or 2
  • ✓Adequate bone marrow function: granulocytes ≥1500/uL, platelets ≥75,000/uL, hemoglobin ≥9 g/dL
Key exclusion· 10
  • ✕Unresolved or irreversible NCI-CTC Grade 3-4 adverse event or clinically meaningful cardiac adverse event (any grade) from parent study that is pertuzumab-related and ongoing
  • ✕Recent or current HER pathway inhibitors (e.g., trastuzumab, gefitinib, erlotinib) or other monoclonal antibodies within 3 months
  • ✕Clinical evidence of CNS or brain metastases
  • ✕Ejection fraction ≤50% by ECHO or MUGA

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00096941
NCT00096941Phase 2Completed
CompareCT.gov

An Open-Label, Multicenter Extension Study of Pertuzumab (rhuMAb 2C4) in Subjects Treated With Pertuzumab in a Previous Genentech-Sponsored Phase II Cancer Study

Genentech, Inc.·interventional·Posted Nov 18, 2004·Updated Jun 11, 2015

In Brief

A Phase 2 clinical trial evaluating Pertuzumab for Solid Cancers. Completed, enrolled 3 participants.

Detailed Summary

This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if they are continuing to receive clinical benefit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Cancers
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 18, 2004
Enrollment StartMay 1, 2005
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 21.6 years ago

Interventions

Pertuzumabdrug

Pertuzumab was supplied as a single-use liquid formulation.