PER-002-17Completed未知
A SINGLE-ARM OPEN-LABEL MULTI-CENTRE EXTENSION STUDY OF PERTUZUMAB ADMINISTERED AS A SINGLE AGENT OR IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS PREVIOUSLY ENROLLED IN A HOFFMANN-LA ROCHE-SPONSORED PERTUZUMAB STUDY.
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Enrollment
- 1
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •*Signed written informed consent approved by the relevant the Ethics Committee (EC) or the Institutional Review Board (IRB).
- •*Prior eligibility for, and receiving pertuzumab as an IMP 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 end.
- •*Investigator’s opinion that the patient continues to benefit from pertuzumab treatment.
Exclusion Criteria
- •*Meets any of the exclusion criteria of the Parent protocol.
- •*Evidence of disease progression.
- •*Permanent discontinuation of pertuzumab for any reason during the Parent study*Any unresolved or irreversible toxicities during the Parent *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 and/or any of the anti-cancer drug(s) given in combination with pertuzumab *Treatment with any anti-cancer treatment (other than any treatment given as permitted in the Parent protocol) *Positive serum pregnancy test in women of childbearing potential. *For WOCBP: A WOCBP who is sexually active and does not agree to use a highly effective contraception. For men: does not agree to remain abstinent or use a condom during and for at least 6 months after the last dose of pertuzumab condom for the duration of the pregnancy.
- •*Concurrent participation in any therapeutic clinical trial (other than the Parent study).
- •*Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Investigators
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