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Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor - Protocol Specific, Breast Cancer - Female

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Trial Information

Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors


This is an open label, dose escalation study to determine the maximum tolerated dose (MTD)
of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid
tumors. There will be a dose expansion cohort of thirty patients to assess detailed
pharmacokinetics and to assess any signal of activity in patients with solid tumors and in a
portion who have breast cancer that is triplenegative (ER-negative, PR-negative, and
HER2-negative).


Inclusion Criteria:



- Confirmed diagnosis of a solid malignancy with advanced disease that has relapsed,
that is refractory to standard therapies, or for which there is not standard therapy,
or for which the patient opts not to receive standard therapy.

- At the recommended phase II dose level, triple-negative breast cancer defined as
ER-negative, PR-negative, and HER2-negative, will be enrolled and another 10 patients
with a solid malignancy who would benefit from a paclitaxel and carboplatin-based
regimen, will also be enrolled.

- Male or female ≥ 18 years of age

- Able to swallow and retain oral medications

Exclusion Criteria:

- Major surgery within last 28 days or cytotoxic chemotherapy, biologic therapy,
investigational agents, or radiotherapy within last 21 days. Patients who have
completed therapy with mitomycin C or nitrosurea will have to wait 42 days.

- More than 3 prior lines of cytotoxic chemotherapy for metastatic disease

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle

Outcome Description:

Toxicity will be assessed every 28 days up to 30 days after the last dose of treatment. Dose limiting toxicity is defined as Non-hematological toxicity ≥ grade 3 (excluding alopecia, nausea, vomiting, or diarrhea for which adequate supportive therapy has not been instituted). Hematologic toxicity: Grade 4 neutropenia lasting ≥ 7 days Grade 4 neutropenia and fever of ≥ 38.5°C ≥ Grade 3 neutropenia with ≥ Grade 3 infection Grade 4 thrombocytopenia Inability to start next cycle of treatment by more than 4 weeks due to unresolved toxicity

Outcome Time Frame:

Up to 30 days after last dose of treatment

Safety Issue:

Yes

Principal Investigator

Antoinette Tan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentisty of New Jersey - Cancer Institute of New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

051101

NCT ID:

NCT01407562

Start Date:

August 2011

Completion Date:

December 2013

Related Keywords:

  • Unspecified Adult Solid Tumor - Protocol Specific
  • Breast Cancer - Female
  • Breast Neoplasms
  • Neoplasms

Name

Location
Cancer Institute of New Jersey New Brunswick, New Jersey  08901