Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors

Conditions

• Advanced Cancers

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Pazopanib — DRUG
  Starting dose: 200 mg by mouth every other day starting on day 1 for 28 days.
• Lapatinib — DRUG
  Starting dose 500 mg by mouth every day for 28 days.
• Trastuzumab (Herceptin®) — DRUG
  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
• Pazopanib — DRUG
  Starting dose 200 mg by mouth every day for 28 days.

Study Details

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 Dates

Start date

Oct 31, 2011

Status verified

Mar 2015

Primary completion

Mar 31, 2015

Completion

Mar 31, 2015

Study Design

Enrollment

43 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Pazopanib in Combination with Lapatinib or Trastuzumab [ Time Frame: 28 day cycle ]

Locations (1)

Find similar trials in Houston, TX

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