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

Neoplasms, Breast Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790816
• Other study ID #: 111767
• Status: Completed
• Phase: Phase 1
• First received: November 13, 2008
• Last updated: February 26, 2018
• Start date: October 2008
• Est. completion date: August 19, 2016

Study information

• Verified date: February 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 19, 2016
• Est. primary completion date: August 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms, Breast

Intervention

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

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Montreal	Quebec
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Songpa-gu, Seoul
Netherlands	Novartis Investigative Site	Amsterdam
Spain	Novartis Investigative Site	Hospitalet de Llobregat (Barcelona)
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Durham	North Carolina
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Lebanon	New Hampshire
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	Santa Monica	California
United States	Novartis Investigative Site	Scottsdale	Arizona
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Korea, Republic of,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		Initiation of study treatment to discontinuation of study treatment
Secondary	Efficacy		Initiation of study treatment to discontinuation of study treatment

External Links

•   Results from the Novartis Clinical Trials Resulkts website