A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enro… (NCT02320435) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Brazil, China, Costa Rica154 participantsStarted 2015-02-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \</= 50%
* Any serious uncontrolled concomitant disease that would contraindicate the use of pertuzumab or that would put the patient at high risk for treatment-re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival
Timeframe: From date of first dose of pertuzumab in this study until the date of disease progression or death, whichever occurs first (up to approximately 10 years)
2
Overall Survival
Timeframe: From date of first dose of pertuzumab in this study until the date of death (up to approximately 10 years)
3
Number of Participants with Adverse Events by Severity, Classified According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Timeframe: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
4
Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption
Timeframe: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
5
Number of Participants with Non-Serious Adverse Events of Special Interest (AESIs)
Timeframe: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
6
Left Ventricular Ejection Fraction (LVEF) Over Time