Status:
COMPLETED
Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
This Phase I, dose finding study evaluates the safety and tolerability of lapatinib, a dual tyrosine kinase inhibitor, and GW786034, an anti-angiogenesis agent, when given together. The study first wi...
Eligibility Criteria
Inclusion
- 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 Tarceva(erlotinib).
- 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 candidate.
- Do not have accessible veins for venipuncture.
- History of prolonged QTc on ECG.
Exclusion
Key Trial Info
Start Date :
September 28 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00158782
Start Date
September 28 2004
End Date
August 21 2007
Last Update
November 17 2017
Active Locations (2)
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1
GSK Investigational Site
Durham, North Carolina, United States, 27705
2
GSK Investigational Site
Rotterdam, Netherlands, 3075 EA