CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 129 enrolled
Drug / intervention
Pertuzumab (rhuMAb 2C4)drug
Likely dose
Not stated in record
Key inclusion· 6
  • Advanced, histologically documented ovarian carcinoma
  • Measurable disease by RECIST (≥20 mm by conventional imaging or ≥10 mm by spiral CT) OR radiologically detectable disease (ascites, peritoneal deposits) with two CA-125 measurements both >2× ULN and ≥40 IU/mL, at least 1 week apart
  • One or more prior platinum-based chemotherapy regimens (carboplatin, cisplatin, or organoplatinum compound)
  • Age ≥18 years
Key exclusion· 9
  • Prior HER pathway inhibitors (trastuzumab, gefitinib, erlotinib, C225, CI1033, TAK165)
  • History or clinical evidence of CNS or brain metastases
  • Ejection fraction <50% on ECHO
  • Uncontrolled hypercalcemia (>11.5 mg/dL)

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

Search/NCT00058552
NCT00058552Phase 2Completed

A Phase II, Open-label, Multicenter Study to Evaluate the Effect of Tumor-based HER2 Activation on the Efficacy of rhuMAb 2C4 (Pertuzumab) in Subjects With Advanced, Refractory or Recurrent Ovarian Cancer

Genentech, Inc.·interventional·Posted Apr 9, 2003·Updated Mar 8, 2017

In Brief

A Phase 2 clinical trial evaluating Pertuzumab (rhuMAb 2C4) for Ovarian Cancer. Completed, enrolled 129 participants.

Detailed Summary

The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced ovarian cancer that is refractory to, or has recurred following, prior chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartMay 1, 2003
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 23.2 years ago

Interventions

Pertuzumab (rhuMAb 2C4)drug