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

February 26, 2018 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 135-710
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 110-744
        • Novartis Investigative Site
      • Songpa-gu, Seoul, Korea, Republic of, 138-736
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Novartis Investigative Site
  • Spain
      • Hospitalet de Llobregat (Barcelona), Spain, 08907
        • Novartis Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Novartis Investigative Site
      • Tucson, Arizona, United States, 85724
        • Novartis Investigative Site
    • California
      • Santa Monica, California, United States, 90404
        • Novartis Investigative Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Novartis Investigative Site
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Novartis Investigative Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Novartis Investigative Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Novartis Investigative Site
    • New York
      • Buffalo, New York, United States, 14263
        • Novartis Investigative Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Novartis Investigative Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Novartis Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Novartis Investigative Site
      • Nashville, Tennessee, United States, 37203
        • Novartis Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Lapatinib monotherapy
Drug: Lapatinib in combination with an anti-cancer agent
Lapatinib in combination with paclitaxel, letrozole, capecitabine, capecitabine/oxaliplatin, gemcitabine, docetaxel, trastuzumab, FOLFOX4, or FOLFIRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: Initiation of study treatment to discontinuation of study treatment
Initiation of study treatment to discontinuation of study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: Initiation of study treatment to discontinuation of study treatment
Initiation of study treatment to discontinuation of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

August 19, 2016

Study Completion (Actual)

August 19, 2016

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111767

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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