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Trial record 8 of 168 for:    pertuzumab

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

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ClinicalTrials.gov Identifier: NCT02320435
Recruitment Status : Recruiting
First Posted : December 19, 2014
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a single-arm, multi-center, open-label extension study designed to provide pertuzumab to patients who continue to derive benefit from pertuzumab, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored Global study who continue to receive pertuzumab at the time of the Parent study end are eligible for continued treatment in this extension study. 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 Perjeta treatment will continue to receive pertuzumab until disease progression, unacceptable toxicities, Investigator decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Pertuzumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 2, 2015
Estimated Primary Completion Date : February 6, 2025
Estimated Study Completion Date : February 6, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Pertuzumab

Arm Intervention/treatment
Experimental: Extension Study
Open-label
Drug: Pertuzumab
Pertuzumab single agent or in combination with other anti-cancer therapies, at the same dose and schedule at which it was given at the end of the Parent study
Other Name: RO4368451; Perjeta




Primary Outcome Measures :
  1. Patients who continue to derive benefit from pertuzumab who were previously enrolled in a Roche-sponsored pertuzumab study (Parent protocol), as assessed by the Investigator [ Time Frame: After the last patient has completed their 7-month follow-up visit post-pertuzumab, unless all patients have withdrawn, have had disease progression, died, been lost to follow-up, or the study is terminated by the Sponsor (whichever occurs first) ]

Secondary Outcome Measures :
  1. Efficacy: Progression-free survival as assessed by investigator; overall survival [ Time Frame: After the last patient has completed their 7-month follow-up visit post-pertuzumab, unless all patients have withdrawn, have had disease progression, died, been lost to follow-up, or the study is terminated by the Sponsor (whichever occurs first) ]
  2. Safety: Incidence of adverse events [ Time Frame: After the last patient has completed their 7-month follow-up visit post-pertuzumab, unless all patients have withdrawn, have had disease progression, died, been lost to follow-up, or the study is terminated by the Sponsor (whichever occurs first) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 </= 50%
  • Any serious uncontrolled concomitant disease that would contraindicate the use of pertuzumab or that would put the patient at high risk for treatment-related complications
  • Treatment with any anti-cancer treatment (other than any treatment given as permitted in the Parent protocol) in the time period between last treatment in the Parent study and the first dose pertuzumab in the extension study (i.e. up to 9 weeks)
  • Positive serum pregnancy test
  • Women of child-bearing potential who are sexually active and do not agree to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception (such as barrier method in conjunction with spermicidal gel) during and for at least 6 months after the last dose or pertuzumab or 7 months after the last dose of trastuzumab or trastuzumab emtansine (T-DM1), if being used in combination
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320435


Contacts
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Contact: Reference Study ID Number: MO29406 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02320435     History of Changes
Other Study ID Numbers: MO29406
2014-002048-42 ( EudraCT Number )
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

Additional relevant MeSH terms:
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Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents