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NCT02320435
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Conditions: Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 154
Sponsor: Hoffmann-La Roche
Location: Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande do Sul
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.
Eligibility Criteria
Inclusion Criteria:
* Informed consent
* Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure
* Investigator's opinion that the patient continues to benefit from treatment
Exclusion Criteria:
* Meets any of the exclusion criteria of the Parent protocol at the time the patient is considered for entry in the extension study
* Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study
* Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study
* Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion below.
* More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study
* Left ventricular ejection fraction \
Source: ClinicalTrials.gov (NCT02320435). StuddyBuddy aggregates publicly available trial information.