Clinical trial NCT00790816: Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents
Official title: An Open-Label Phase Ib Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-Cancer Treatment in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Breast
Keywords: Cancer
lapatinib
Combination therapy
Chronic administration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to provide continued access to lapatinib as monotherapy or as part of a combination regimen to cancer subjects who are currently participating in a phase I trial that has met its study objectives.


Eligibility criteria: Inclusion Criteria:

* Participation in a Phase I lapatinib trial that has met its study objectives.
* 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:

* Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
* 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).

Primary outcomes:
measure: Safety and tolerability
timeFrame: Initiation of study treatment to discontinuation of study treatment
Secondary outcomes:
measure: Efficacy
timeFrame: Initiation of study treatment to discontinuation of study treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Santa Monica
country: United States
facility: Novartis Investigative Site
state: California
city: Washington
country: United States
facility: Novartis Investigative Site
state: District of Columbia
city: Fort Myers
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Detroit
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Lebanon
country: United States
facility: Novartis Investigative Site
state: New Hampshire
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Memphis
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Songpa-gu, Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Hospitalet de Llobregat (Barcelona)
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: