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Study Summary
No. 2009-0009:.......Brain; CNS......Marta Penas-Prado......Neuro Oncology
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Study Summary Title
Study Summary
Number:
2009-0009
Study Title:An Open-Label, Phase Ib Study to Assess the Long-Term Safety
Profile of Pazopanib in Cancer Patients
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Physician New Patient Referral
Name:Marta Penas-PradoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Neuro OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2833
Contact us about clinical trials
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General Information
Disease Group:Brain
CNS
Supported By:The GlaxoSmithKline group of companies
Phase of Study:Phase IReturn
Visit:
Every 12 weeks
Treatment
Agents:
GW786034
Lapatinib
Home Care:Patients will take the study drug at home
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to learn about the long-term safety
of pazopanib when given in combination with lapatinib to patients with
glioblastoma.
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Study Objectives / Outcomes
To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:09/10/2009
Study Type:Phase I
Recruitment Status:Closed
Projected Accrual:200
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Subject has completed participation in a GSK-sponsored study of pazopanib and remains eligible for continued treatment with pazopanib. Subjects will be stratified into: Group 2 - monotherapy study of pazopanib; or Group 3 - combination of pazopanib and lapatinib with or without another approved marketed agent(s). i. Remains eligible for continued treatment with lapatinib. ii. Has a left ventricular ejection fraction (LVEF) >/=50% based on ECHO or MUGA or within the institutional normal range;

2) ( 1. continued) or Group 4 - combination of pazopanib and an approved marketed agent(s), other than lapatinib. i. Remains eligible for continued treatment with approved marketed agent(s), other than lapatinib.

3) Women subject: 1) Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is: a) pre-menopausal with a documented bilateral oophorectomy (ovariectomy), bilateral tubal ligation or hysterectomy b) post-menopausal defined as a total cessation of menses for >/=1 year (in questionable cases, a blood sample with simultaneous follicle stimulating hormone [FSH] >40 MlU/mL and estradiol <40 pg/mL <140 pmol/L] is confirmatory).

4) ( 3. continued) 2) Child-bearing potential who has a negative serum pregnancy testing at time of transition to this study, and agrees to use 1 of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point.

5) Subject is a man with a female partner of childbearing potential agrees to use contraception with acceptable methods.

6) Subject, if sexually active, agrees to continue the recommended contraceptive measures for the duration of treatment and for 28 days following discontinuation of treatment.

7) Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria: 1) Subject had treatment with pazopanib permanently discontinued during the parent study due to intolerance or treatment failure. 2) Subject has a treatment-related SAE that began during participation in the parent pazopanib study and remains unresolved or unstable. 3) Subject has poorly controlled hypertension (systolic blood pressure [SBP] of 140 mmHg or higher and/or diastolic blood pressure [DBP] of 90 mmHg or higher). 4) Subject is considered medically unfit for the study by the investigator as a result of the medical interview, physical examination or other baseline investigations. 5) Subject is pregnant or breastfeeding. 6) Subject is unwilling or unable to follow the procedures outlined in the protocol.
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Links
Registration Number: NCT00387205 Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results
Return to Clinical Trials at M.D. Anderson Cancer Center