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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02320435
Recruitment Status : Recruiting
First Posted : December 19, 2014
Last Update Posted : February 13, 2020
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 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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Pertuzumab Drug: Trastuzumab Drug: Other Combination Anti-Cancer Therapies 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 : May 24, 2025
Estimated Study Completion Date : May 24, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Pertuzumab

Arm Intervention/treatment
Experimental: Pertuzumab (Single-Agent or Combination Therapy)
Pertuzumab will continue to be administered as a single agent or in combination with other anti-cancer therapies at the same dose, schedule, and guidelines that were in effect at the end of the Parent study.
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.
Other Names:
  • RO4368451
  • Perjeta

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.




Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: From date of first dose of pertuzumab in the Parent study until the date of disease progression or death, whichever occurs first (up to approximately 10 years) ]
  2. Overall Survival [ Time Frame: From date of first dose of pertuzumab in the Parent 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 [ Time Frame: Baseline up to approximately 10 years ]
  4. Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption [ Time Frame: Baseline up to approximately 10 years ]
  5. Number of Participants with Non-Serious Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to approximately 10 years ]
    Non-serious AESIs for this study include the following: Cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law; Suspected transmission of an infectious agent by the study drug; or, An asymptomatic decline in left ventricular ejection fraction (LVEF) requiring treatment or leading to discontinuation of human epidermal growth factor receptor 2 (HER2)-targeted therapies.

  6. Left Ventricular Ejection Fraction (LVEF) Over Time [ Time Frame: Baseline, every 3 treatment cycles (1 cycle is 21 days), and 28 days after last dose of pertuzumab (up to approximately 10 years) ]


Information from the National Library of Medicine

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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 and men with partners of childbearing potential who do not agree to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner for the duration of study treatment and for at least 7 months after the last dose of study medication. Male patients who do not agree to refrain from donating sperm during this same period. Male patients whose partner is pregnant who do not agree to use condoms 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

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

Locations
Show Show 62 study locations
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    
Other Study ID Numbers: MO29406
2014-002048-42 ( EudraCT Number )
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Trastuzumab
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents