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An Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study of Multiple Doses of GW786034 and Lapatinib Concomitantly Administered in Cancer Patients.

Phase 1
21 Years
Not Enrolling
Carcinoma, Renal Cell, Cancer

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Trial Information

An Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study of Multiple Doses of GW786034 and Lapatinib Concomitantly Administered in Cancer Patients.

Inclusion Criteria

Inclusion criteria:

- Histologically or cytologically confirmed diagnosis of advanced solid tumor
refractory to standard therapy or for whom there is no standard therapy.

- Females are eligible if they are of:

a) Non-childbearing potential (i.e., physiologically incapable of becoming pregnant),
including any female who:

- had a hysterectomy.

- had a bilateral oophorectomy (ovariectomy).

- had a bilateral tubal ligation.

- is post-menopausal (a demonstration of total cessation of menses for 1 year).

- childbearing potential, has a negative serum pregnancy test at screening, and agrees
to one of the following:

- an IUD with a documented failure rate of less than 1% per year.

- vasectomized partner who is sterile prior to the female patient's entry and is the
sole sexual partner for that female.

- complete abstinence from sexual intercourse for 14 days before exposure to
investigational product, throughout the clinical trial, and for at least 14 days
after the last dose of investigational product.

- double-barrier contraception (condom with spermicidal jelly, foam suppository, or
film; diaphragm with spermicide; or male condom and diaphragm with spermicide).

- ECOG (Eastern Cooperative Oncology Group) PS 0 or 1.

- Adequate bone marrow function.

- Platelets greater than or equal to 75,000/mm3.

- ANC greater than or equal to 1,500/mm3 (1.5 x 109/L).

- Hgb greater than or equal to 9 g/dL (5 mmol/L).

- CLcr > 50 mL/min as calculated by the Cockcroft-Gault formula.

- Total bilirubin less than or equal to 1.5 x upper limit of normal.

- PT/INR/PTT less than or equal to 1.2 x upper limit of normal.

- AST/ALT less than or equal to 3 x upper limit of normal.

- Has LVEF within normal range or above 50% based on MUGA/ECHO.

- Urinalysis for protein is < 2 (negative, trace, or 1). NOTE: If urinalysis is 2 or
greater then a 24 hour urine for protein must demonstrate less than 1 gram of protein
in 24 hours for patient to be eligible for enrollment.

- Able to swallow and retain oral medication.

- Has a life expectancy of at least 12 weeks.

Exclusion criteria:

- Had prior treatment with either study drug.

- Has brain metastases.

- Uncontrolled hypertension (BP higher than 150/90 SBP/DBP).

- Have heart failure.

- Have DVT (deep vein thrombosis) or arterial thrombosis, MI (myocardial infarction),
angina, or has had angioplasty and/or stenting within last 3 months.

- Has allergy to drug similar to lapatinib (e.g. allergic to Iressa(gefitinib) or

- Is using therapeutic doses of anti-coagulant.

- Has had major surgery, hormonal therapy, chemotherapy, radiotherapy, or other
investigational agent within last 28 days.

- Pregnant or lactating.

- History or current GI (gastrointestinal) condition that alters stomach or gut
emptying from normal (e.g. major surgery on the stomach).

- Bowel obstruction or chronic diarrhea.

- Psychological or geographical conditions that would prevent him/her from being a good

- Do not have accessible veins for venipuncture.

- History of prolonged QTc on ECG.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in pre and post treatment lab values and monitoring/reporting AES.AE's throughout study

Outcome Time Frame:

throughout study

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:



European Union: European Medicines Agency

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Carcinoma, Renal Cell
  • Cancer
  • Cancer GW786034 Lapatinib Pazopanib
  • Carcinoma
  • Carcinoma, Renal Cell



GSK Investigational Site Raleigh, North Carolina  27609