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An Open-Label Phase Ib Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-Cancer Treatment in Patients With Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors, Neoplasms, Breast, Cancer

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Trial Information

An Open-Label Phase Ib Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-Cancer Treatment in Patients With Solid Tumors


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

Initiation of study treatment to discontinuation of study treatment

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Canada: Health Canada

Study ID:

111767

NCT ID:

NCT00790816

Start Date:

October 2008

Completion Date:

April 2013

Related Keywords:

  • Solid Tumors
  • Neoplasms, Breast
  • Cancer
  • Cancer
  • lapatinib
  • Combination therapy
  • Chronic administration
  • Breast Neoplasms
  • Neoplasms

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteHooksett, New Hampshire  03106
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteWashington, District of Columbia  20307-5001
GSK Investigational SiteSalt Lake City, Utah  84107