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Carcinoma, Renal CellPhase 1NCT00158782

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

A Phase 1 study testing GW786034 and lapatinib in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
GW786034 and lapatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesin 2 countries
Study dates
28 Sep 2004to 21 Aug 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • GSK Investigational Site

    Durham, North Carolina, 27705

Other trials in United States

Netherlands1 site

  • GSK Investigational Site

    Rotterdam, 3075 EA

Other trials in Netherlands

About this study

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

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.

Being tested
GW786034, lapatinib
Keywords
Cancer GW786034 Lapatinib Pazopanib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GW786034Drug

    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.

  • lapatinibDrug

    Lapatinib is an oral, reversible, tyrosine kinase inhibitor of both epidermal growth factor receptor-1 (ErbB1) and ErbB2.

Study groups in NCT00158782
Study groupRoleWhat they receive
Cohort 1ExperimentalSubjects will receive GW786034 500 milligrams and lapatinib 750 milligrams.
Receives: Drug: GW786034; Drug: lapatinib
Cohort 2ExperimentalSubjects will receive GW786034 250 milligrams and lapatinib 750 milligrams.
Receives: Drug: GW786034; Drug: lapatinib
Cohort 3ExperimentalSubjects will receive GW786034 250 milligrams and lapatinib 1000 milligrams.
Receives: Drug: GW786034; Drug: lapatinib
Cohort 4ExperimentalSubjects will receive GW786034 500 milligrams and lapatinib 1000 milligrams.
Receives: Drug: GW786034; Drug: lapatinib
Cohort 5ExperimentalSubjects will receive GW786034 250 milligrams and lapatinib 1250 milligrams.
Receives: Drug: GW786034; Drug: lapatinib
Cohort 6ExperimentalSubjects will receive GW786034 400 milligrams and lapatinib 1250 milligrams.
Receives: Drug: GW786034; Drug: lapatinib
Cohort 7ExperimentalSubjects will receive GW786034 200 milligrams and lapatinib 1500 milligrams.
Receives: Drug: GW786034; Drug: lapatinib
Cohort 8ExperimentalSubjects will receive GW786034 400 milligrams and lapatinib 1500 milligrams.
Receives: Drug: GW786034; Drug: lapatinib
Cohort 9ExperimentalSubjects will receive GW786034 400 milligrams and lapatinib 1000 milligrams.
Receives: Drug: GW786034; Drug: lapatinib
Cohort 10ExperimentalSubjects will receive GW786034 800 milligrams and lapatinib 1500 milligrams.
Receives: Drug: GW786034; Drug: lapatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: throughout study

  2. Labs every wk first cycle:day 1 subsequent cycles

    Measured: first cycle:day 1 subsequent cycles

Secondary outcomes (1)

  1. 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

    Measured: Blood taken day 15, 22 or 37 and tumor assessed every 8 wks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study start28 Sep 2004
  3. Primary completion21 Aug 2007
  4. Study completion21 Aug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00158782
Sponsor's protocol ID
VEG10006
Status last verified
Nov 2017
First submitted
8 Sep 2005
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GW786034 and lapatinib in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in pre and post treatment lab values and monitoring/reporting AES.AE's throughout study (time frame: throughout study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00158782, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.

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