Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01454804
First received: October 12, 2011
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers |
Drug: Pazopanib Drug: Lapatinib Drug: Trastuzumab (Herceptin®) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Pazopanib in Combination With Lapatinib or Trastuzumab in Subjects With Solid Tumors |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum tolerated dose (MTD) of pazopanib in combination with lapatinib or trastuzumab [ Time Frame: 28 day cycle ] [ Designated as safety issue: Yes ]MTD is defined as highest dose in which incidence of dose limiting toxicity (DLT) was less than 33% (approximately two or more participants in a dose cohort).
- Tumor Response [ Time Frame: End of second 28 day cycle ] [ Designated as safety issue: No ]Computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, positron emission tomography (PET) scan, and/or x-ray to check the status of the disease. Tumor response calculated by RECIST and World Health Organization Working Group (WHO) criteria. A tumor response is defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria, (3) decrease in tumor markers by more than or equal to 25% or (4) a partial response according to the Choi criteria.
| Estimated Enrollment: | 174 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A: Pazopanib + Lapatinib
Oral Pazopanib 200 mg every other day starting on day 1 and oral Lapatinib 500 mg daily starting day 1, both for 28 days.
|
Drug: Pazopanib
Starting dose: 200 mg by mouth every other day starting on day 1 for 28 days.
Other Name: GW78634
Drug: Lapatinib
Starting dose 500 mg by mouth every day for 28 days.
Other Names:
|
|
Experimental: Arm B: Pazopanib + Trastuzumab
Oral Pazopanib 200 mg daily for 28 day cycle and Trastuzumab (Herceptin®) 4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1, with a maintenance dose of 2 mg/kg every week as 30 minute infusion by vein.
|
Drug: Trastuzumab (Herceptin®)
4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1. Maintenance dose of 2 mg/kg every week as 30 minute infusion by vein. Dose Expansion Phase: Maximum tolerated dose (MTD) from Dose Escalation Phase Other Name: Herceptin
Drug: Pazopanib
Starting dose 200 mg by mouth every day for 28 days.
Other Name: GW78634
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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/, 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 EGFR mutation.
Exclusion Criteria:
- 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%.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454804
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | David S. Hong, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01454804 History of Changes |
| Other Study ID Numbers: | 2011-0650 |
| Study First Received: | October 12, 2011 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancers Solid Tumors Pazopanib GW786034 Lapatinib |
Tykerb GW572016 Trastuzumab Herceptin |
Additional relevant MeSH terms:
|
Neoplasms Trastuzumab Lapatinib Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013