A Two-Cohort Phase I/II Trial of PTK787 and Pemetrexed With or Without Cisplatin in Patients With Advanced Non-Small Cell Lung Cancers and Malignant Pleural Mesotheliomas
This is an open-label, two-arm, multicenter Phase IA/II dose-escalation study of PTK787 in
combination with Pemetrexed alone (Cohort 1) or Pemetrexed and Cisplatin (Cohort 2).
This study is designed to determine the maximum tolerated dose (MTD) and dose limiting
toxicity (DLT) of PTK787 when administered in combination with Pemetrexed or Pemetrexed and
Cisplatin, and to characterize the safety, tolerability, biologic activity, and PK profile
of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas.
In cohort 1, PTK787 will be administered orally every 12 hours on days 2-42 of a 42-day
cycle. In addition, Pemetrexed will be administered on days 1 and 22.
In cohort 2, PTK787 will be administered orally every 12 hours on days 2-42 of a 42 day
cycle. In addition, Pemetrexed will be administered on days 1 and 22. Thirty minutes after
Pemetrexed administration, Cisplatin will be infused on days 1 and 22.
In the current study, initially patients will be treated on Cohort 1 (Pemetrexed + PTK787).
Once an MTD determination is made on this cohort (or PTK787 has been escalated to the
maximum dose of 750 mg Q12h enrollment will begin on Cohort 2. At the MTD dose, both cohorts
will be expanded to a minimum of 20 patients to determine additional safety of the
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the Maximum tolerated dose (MTD) and Dose Limiting toxicities (DLTs) of a combination of Pemetrexed and PTK787/ZK222584 (Cohort 1) and a combination of Pemetrexed with Cisplatin and PTK787/ZK222584 (Cohort 2) in patients
Sunil Sharma, MD
Nevada Cancer Institute
United States: Food and Drug Administration
|Nevada Cancer Institute||Las Vegas, Nevada 89135|