Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced Colorectal Cancer

Completed · Phase 1

Conditions studied: Neoplasms, Colorectal

In brief

The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.

Key facts

Study ID

NCT00536809

Run by

GlaxoSmithKline

People needed

12

Starts

2007-09-26

Expected to finish

2008-10-31

Last updated by the study team

2017-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older.
• A female is eligible to enter and participate in the study if she is of:
• Non-child-bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
• Has had a hysterectomy, or
• Has had a bilateral oophorectomy (ovariectomy), or
• Has had a bilateral tubal ligation, or
• Is considered post-menopausal (defined as amenorrheic for greater than or equal to 1 year).
• Childbearing potential, has a negative serum pregnancy test at Screening and agrees to one of the following from 2 weeks prior to enrolment and continue through the post-study visit:
• Complete abstinence from sexual intercourse
• Oral Contraceptive, either combined or progestogen alone (must use a back up method, if have taken for less than 3 cycles)
• Injectable progestogen
• Implants of levonorgestrel
• Estrogenic vaginal ring
• Percutaneous contraceptive patches
• Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
• Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
• Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
• Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
• Provided written informed consent.
• Hemoglobin greater than or equal to 8 gm/dL (5 nmol/L), if clinically stable.
• Absolute neutrophil count greater than or equal to 1,500/mm\^3 (1.5 x 109/L).
• Calculated creatinine clearance (CrCl) greater than or equal to 50 mls/min.
• Total bilirubin less than or equal to 1.25 times the institutional upper limit of normal (ULN).
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2 times the ULN. For subjects with liver metastases: AST or ALT less than or equal to 5 times the ULN.
• LVEF greater than or equal to 50% or greater than or equal to LLN for the institution based on multiple gated acquisition scan (MUGA) or echocardiogram (ECHO).

Where it is running

• GSK Investigational Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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