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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial

NCT02320435 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-05-12

No results posted yet for this study

Summary

This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.

Conditions

Interventions

DRUG

Pertuzumab

In general, patients will continue to receive 420 milligrams (mg) of pertuzumab administered as an intravenous infusion every 3 weeks following the guidance of the Parent protocol.

DRUG

Trastuzumab

If trastuzumab intravenous infusions were given in combination with pertuzumab as part of the Parent study, patients will continue to receive treatment at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.

DRUG

Other Combination Anti-Cancer Therapies

If other anti-cancer therapies were given in combination with pertuzumab as part of the Parent study, patients will receive all treatments at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-02
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Brazil
  • China
  • Costa Rica
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Ukraine

Study Locations

More Related Trials

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 NCT02320435 on ClinicalTrials.gov