CompletedNCT00158782Updated Nov 17, 2017

Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients

A Phase 1 interventional study of GW786034 and lapatinib in Carcinoma, Renal Cell, sponsored by GlaxoSmithKline. Completed at 2 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 11 months after the study started (first participant enrolled Sep 2004, registered Sep 2005).

Phase: Phase 1
Study type: Interventional
Enrollment: 75
Allocation: Non-randomized
Ages: 21 Years and older
Sex: All

Study 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 will find the best doses using safety and blood concentration data of both agents. This is done enrolling stepwise, cohorts of 3 patients each and the last patient enrolled must reach at least Day 22 of continuous daily dosing before the next cohort at an increased dose can begin. If a patient in a cohort has a dose limiting toxicity before Day 22, then 3 more patients are studied at that same dose. If 2 of 6 patients have dose limiting toxicities within the first 22 days, the next cohort receives the next lowest dose. Otherwise each cohort has an increasing dose of one of the two agents. The second stage of the study will administer the best doses of the agents to about 16 patients to further study safety and collect more blood concentration data (more blood samples in the second phase compared to the first phase). The second stage has the advantage of using the best dose (decreases chance of receiving a sub-therapeutic dose) while it collects more blood samples and requires slightly more long clinic visits.

Conditions studied

Carcinoma, Renal Cell

Browse trials for

Carcinoma, Renal Cell 1,965

Keywords

Cancer GW786034 Lapatinib Pazopanib

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 75 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 75 participants (actual)

Study arms

Experimental
Cohort 1
Subjects will receive GW786034 500 milligrams and lapatinib 750 milligrams.
Drug: GW786034 · Drug: lapatinib
Experimental
Cohort 2
Subjects will receive GW786034 250 milligrams and lapatinib 750 milligrams.
Drug: GW786034 · Drug: lapatinib
Experimental
Cohort 3
Subjects will receive GW786034 250 milligrams and lapatinib 1000 milligrams.
Drug: GW786034 · Drug: lapatinib
Experimental
Cohort 4
Subjects will receive GW786034 500 milligrams and lapatinib 1000 milligrams.
Drug: GW786034 · Drug: lapatinib
Experimental
Cohort 5
Subjects will receive GW786034 250 milligrams and lapatinib 1250 milligrams.
Drug: GW786034 · Drug: lapatinib
Experimental
Cohort 6
Subjects will receive GW786034 400 milligrams and lapatinib 1250 milligrams.
Drug: GW786034 · Drug: lapatinib
Experimental
Cohort 7
Subjects will receive GW786034 200 milligrams and lapatinib 1500 milligrams.
Drug: GW786034 · Drug: lapatinib
Experimental
Cohort 8
Subjects will receive GW786034 400 milligrams and lapatinib 1500 milligrams.
Drug: GW786034 · Drug: lapatinib
Experimental
Cohort 9
Subjects will receive GW786034 400 milligrams and lapatinib 1000 milligrams.
Drug: GW786034 · Drug: lapatinib
Experimental
Cohort 10
Subjects will receive GW786034 800 milligrams and lapatinib 1500 milligrams.
Drug: GW786034 · Drug: lapatinib

Interventions

DrugGW786034
GW786034 (Pazopanib) is an orally active, potent, reversible, small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor 1 (VEGFR-1), VEGFR-2, VEGFR-3, platelet-derived growth factor receptor-alpha (PDGFR-alpha), PDGFR-beta, and c-Kit.
Druglapatinib
Lapatinib is an oral, reversible, tyrosine kinase inhibitor of both epidermal growth factor receptor-1 (ErbB1) and ErbB2.

What researchers measure

Primary outcomes

Changes in pre and post treatment lab values and monitoring/reporting AES.AE's throughout study
Time frame: throughout study
Labs every wk first cycle:day 1 subsequent cycles
Time frame: first cycle:day 1 subsequent cycles

Secondary outcomes

find max conc of drugs in blood and time it occurs find out if drugs are taken up by the body, how much/for how long find out if drugs affect the size of the tumor. Blood taken day 15, 22 or 37 and tumor assessed every 8 wks
Time frame: Blood taken day 15, 22 or 37 and tumor assessed every 8 wks

Study locations

2 sites

GSK Investigational Site
Durham, North Carolina 27705, United States
GSK Investigational Site
Rotterdam, 3075 EA, Netherlands

References and documents

Publications

de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6. PubMed 23054212 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00158782
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Sep 12, 2005
Start date: Sep 28, 2004
Primary completion: Aug 21, 2007
Completion: Aug 21, 2007
Last update: Nov 17, 2017

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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