Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents
NCT ID: NCT00790816
Last Updated: 2018-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
500 participants
INTERVENTIONAL
2008-10-31
2016-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Study Drug
Lapatinib
Lapatinib monotherapy
Lapatinib in combination with an anti-cancer agent as specified by parent protocol
Lapatinib in combination with an anti-cancer agent as specified by parent protocol
Group 2
Study Drug
Lapatinib in combination with an anti-cancer agent
Lapatinib in combination with paclitaxel, letrozole, capecitabine, capecitabine/oxaliplatin, gemcitabine, docetaxel, trastuzumab, FOLFOX4, or FOLFIRI
Lapatinib
Lapatinib monotherapy
Interventions
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Lapatinib in combination with an anti-cancer agent
Lapatinib in combination with paclitaxel, letrozole, capecitabine, capecitabine/oxaliplatin, gemcitabine, docetaxel, trastuzumab, FOLFOX4, or FOLFIRI
Lapatinib
Lapatinib monotherapy
Lapatinib in combination with an anti-cancer agent as specified by parent protocol
Lapatinib in combination with an anti-cancer agent as specified by parent protocol
Eligibility Criteria
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Inclusion Criteria
* Ability to understand and provide written informed consent to participate in this study.
* Male or female greater than or equal to 18 years of age.
* A female subject is eligible to participate if she is of:
* Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods stated in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
* Child-bearing potential, has a negative serum pregnancy test at baseline, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception from two weeks prior to the administration of study drug and throughout the entire active study treatment period until four weeks after the last dose of study medication.
Exclusion Criteria
* Is a pregnant or lactating female.
* Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or baseline investigations.
* Currently receiving treatment with any medications listed on the prohibited medication listed in the protocol
* Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
* Have current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Scottsdale, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Santa Monica, California, United States
Novartis Investigative Site
Washington D.C., District of Columbia, United States
Novartis Investigative Site
Fort Myers, Florida, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
Lebanon, New Hampshire, United States
Novartis Investigative Site
Buffalo, New York, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Greenville, South Carolina, United States
Novartis Investigative Site
Memphis, Tennessee, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Songpa-gu, Seoul, , South Korea
Novartis Investigative Site
Hospitalet de Llobregat (Barcelona), , Spain
Countries
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Other Identifiers
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111767
Identifier Type: -
Identifier Source: org_study_id
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