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Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00790816•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (23)

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

Key Dates

Start Date

October 1, 2008

Primary Completion Date

August 19, 2016

Completion Date

August 19, 2016

Last Updated

February 28, 2018

Enrollment

500

ACTUAL participants

Conditions

Neoplasms, Breast

Interventions

Lapatinib in combination with an anti-cancer agent

DRUG

Lapatinib

DRUG

Lapatinib in combination with an anti-cancer agent as specified by parent protocol

DRUG

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

NCT04915755

Neoplasms, Breast

View study

COMPLETEDPHASE3

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

NCT00490139

Neoplasms, Breast

View study

TERMINATEDPHASE3

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients