A Multi-Center, Randomized, Double-Blind Phase II Study Comparing ABT-888, a PARP Inhibitor, versus Placebo with Temozolomide in Patients with Relapsed Sensitive or Refractory Small Cell Lung Cancer
To demonstrate an improvement in progression free survival at four months in patients with relapsed sensitive or refractory SCLC receiving ABT-888 and temozolomide compared to placebo and temozolomide. To determine the safety and tolerability of ABT-88 and temozolomide in patients with SCLC.
Histologically confirmed SCLC which has progressed or relapsed after 1 or 2 prior chemotherapy regimens one of which must have been an etoposide platinum doublet. Disease must be sensitive or refractory. Good performance status with normal organ and marrow function. There must be measurable disease. Asymptomatic brain metastases are allowed and if patient is still on steroids, it must be a stable dose. No leptomeningeal involvement or history of seizures. Must be at least 3 weeks and patient has recovered from prior chemotherapy or radiotherapy.
This is a double-blind randomized trial to receive ABT-888 or Placebo with Temozolomide. A cycle is 28 days (4 weeks). The ABT-888 or Placebo will be taken orally on days 1-7 of week 1. The temozolomide will be taken on days 1-5 of week 1. Patients will fast 2 hours before and 1 hour after Temozolomide (water is allowed during this time). Antiemetics will be taken 30 minutes prior to taking Temozolomide. Capsules are to be swallowed whole and taken in rapid succession with 250 mL of water. Treatment will continue until disease progression, unacceptable toxicity, patient chooses to withdraw or investigatorï¿½s decision that changes in the patientï¿½s condition would prevent further treatment on the trial.
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