Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Cancers

In brief

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. The safety of the drug combinations will also be studied. Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells. Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking 2 proteins on the surface of the cancer cell, which are HER 1 and HER 2 receptors. Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the Her2/neu receptor.

Key facts

Study ID: NCT01454804
Run by: M.D. Anderson Cancer Center
People needed: 43
Starts: 2011-10-01
Expected to finish: 2015-03-01
Last updated by the study team: 2016-04-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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%.

Where it is running

University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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