A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 3/31/2019 |
Start Date: | October 16, 2008 |
End Date: | September 21, 2022 |
Contact: | Reference Study ID Number: BO25430 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study
This is a global, multicenter, open-label safety extension study. Participants receiving
single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with
other agents in a Genentech/Roche-sponsored parent study who are active and deriving benefit
at the closure of parent study are eligible for continued treatment in this study.
single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with
other agents in a Genentech/Roche-sponsored parent study who are active and deriving benefit
at the closure of parent study are eligible for continued treatment in this study.
Inclusion Criteria:
- Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine
treatment in the parent study or who continue to receive single-agent trastuzumab
emtansine or combination trastuzumab emtansine treatment at the time of the parent
study closure and received the last study drug dose within the 6 weeks (42 days) prior
to the first dose of study therapy on the extension study or Continue to receive
treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of
the parent study closure if the participant received the last dose of control arm
study drug within the 6 weeks (42 days) prior to the first dose of control arm study
therapy in the extension study
- Participants in the control arm from Study BO21976/TDM4450g whose disease progression
has occurred during the transition interval between the parent study and this
extension study may initiate trastuzumab emtansine treatment at the time of enrollment
into study TDM4529g (NCT00781612)
- Expectation by the investigator that the participant may continue to benefit from
additional single-agent trastuzumab emtansine or combination trastuzumab emtansine
treatment or Expectation of the investigator that the participant may continue to
benefit from control arm treatment as given in study BO21976/TDM4450g and at the time
of disease progression may benefit from single-agent trastuzumab emtansine treatment
- Women of childbearing potential and men with partners of childbearing potential, must
be willing to use a highly effective form of non-hormonal contraception or two
effective forms of non-hormonal contraception by the participants and/or partner, and
to continue the use of contraception for the duration of study treatment and for at
least 7 months after the last dose of study treatment
- Male participants whose partners are pregnant should use condoms for the duration of
the pregnancy
Exclusion Criteria:
- AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine
treatment discontinuation in the parent study
- Ongoing SAEs from the parent study
- Progressive disease on single-agent trastuzumab emtansine or a trastuzumab
emtansine-containing regimen during the parent study or before starting the extension
study, with the exception of participants from study TDM4688g (NCT00943670) with early
disease progression who went on to receive pertuzumab + trastuzumab emtansine
treatment and have not experienced further disease progression on the combination
regimen
- Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National
Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version
3.0 or 4.0, as utilized in the parent study
- History of symptomatic congestive heart failure ([CHF]; New York Heart Association
[NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable
angina, or history of myocardial infarction within 6 months prior to study entry
- Severe dyspnea at rest due to complications of advanced malignancy or current
requirement for continuous oxygen therapy
- Current severe, uncontrolled systemic disease (for example [e.g.] clinically
significant cardiovascular, pulmonary, or metabolic disease)
- Major surgical procedure or significant traumatic injury within 28 days prior to study
entry or anticipation of the need for major surgery during the course of study
treatment
- Current pregnancy or lactation
- History of receiving any investigational treatment or other systemic therapy directed
at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's
last study drug dose in the parent study
- History of hypersensitivity with previous trastuzumab emtansine or any agent used with
trastuzumab emtansine in the parent study, precluding further dosing
- Assessed by the investigator to be unable or unwilling to comply with the requirements
of the protocol
We found this trial at
61
sites
607 S New Ballas Rd
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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1351 Kimberly Rd
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
Columbus, Ohio 43219
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
Fort Myers, Florida 33916
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2406 Century Place Southeast
Hickory, North Carolina 28602
Hickory, North Carolina 28602
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535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
Marietta, Georgia 30060
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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5050 Northeast Hoyt Street
Portland, Oregon 97227
Portland, Oregon 97227
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
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1600 Divisadero Street
San Francisco, California 94115
San Francisco, California 94115
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3402 West Doctor Martin Luther King Junior Boulevard
Tampa, Florida 33607
Tampa, Florida 33607
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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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