Status:
COMPLETED
Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancers
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of the combinations of pazopanib and either lapatinib or trastuzumab that can be given to patients with advanced cancer. ...
Detailed Description
Study Groups: If you are found to be eligible to take part in this study, your doctor will decide which study drugs you will receive based on the disease type and the drugs you have taken in the past...
Eligibility Criteria
Inclusion
- Patients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months.
- Patients must have measurable or evaluable disease.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
- Abnormal organ function is permitted; however, patients must have : Plt \>/=100,000/, absolute neutrophil count (ANC) \>/=1500, total Bilirubin \</=2.0 mg/dl, Creatinine \</=2.0 mg/dl and Prothrombin Time/International Normalized Ratio/Partial Thromboplastin Time (PT/INR/PTT) within 1.5 X upper limit of normal (ULN).
- A woman is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation, is post-menopausal (total cessation of menses for ≥ 1 year); OR if of childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception.
- A man with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study.
- Signed informed consent approved by the Institutional Review Board prior to patient entry.
- Expanded Cohort only: Patients must have HER2 amplification, HER2 mutation, c-Met amplification, c-Met mutation, EML4-ALK translocation, or epidermal growth factor receptor (EGFR) mutation.
Exclusion
- Poorly-controlled hypertension (systolic blood pressure \[SBP\] \>/= 140 mmHg, or diastolic blood pressure \[DBP\]\>/= 90 mmHg).
- Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes,congestive cardiac failure )
- History of myocardial infarction, admission for unstable angina, cardiac angioplasty or stenting within three months of Day 1 of treatment period.
- History of venous or arterial thrombosis within 3 months of Day 1 of treatment Period.
- Current use of therapeutic warfarin. NOTE: both low molecular weight heparin and prophylactic low-dose warfarin are permitted; however, PT/PTT must meet above inclusion criteria.
- Excessive risk of bleeding or thrombosis as defined by stroke or severe bleeding within the prior 6 months.
- Patients who received investigational drugs, chemotherapy or immunotherapy patient must be \>/= five half-lives or \>/= 3 weeks from the last dose of treatment, whichever is shorter.
- Any major surgery or radiotherapy within 14 days of treatment.
- Patients with a documented Left Ventricular Ejection Fraction \< 45%.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01454804
Start Date
October 1 2011
End Date
March 1 2015
Last Update
April 13 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030