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Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00790816
Recruitment Status : Completed
First Posted : November 14, 2008
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Neoplasms, Breast Drug: Lapatinib in combination with an anti-cancer agent Drug: Lapatinib Drug: Lapatinib in combination with an anti-cancer agent as specified by parent protocol Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2008
Primary Completion Date : August 19, 2016
Study Completion Date : August 19, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1
Study Drug
Drug: Lapatinib
Lapatinib monotherapy
Drug: 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
Experimental: Group 2
Study Drug
Drug: Lapatinib in combination with an anti-cancer agent
Lapatinib in combination with paclitaxel, letrozole, capecitabine, capecitabine/oxaliplatin, gemcitabine, docetaxel, trastuzumab, FOLFOX4, or FOLFIRI
Drug: Lapatinib
Lapatinib monotherapy


Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Initiation of study treatment to discontinuation of study treatment ]

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: Initiation of study treatment to discontinuation of study treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

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): NCT00790816


  Show 23 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00790816     History of Changes
Other Study ID Numbers: 111767
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cancer
lapatinib
Combination therapy
Chronic administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lapatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action