A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination with Pemetrexed Versus Pemetrexed Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer

Update Il y a 4 ans
Reference: EUCTR2006-002830-38

Woman and Man

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Extract

The primary objective of the Phase 1 portion of the study, which will be conducted in the US only, is to determine the maximum tolerated dose (MTD) of ABT-751 when administered daily for 14/21 days, in combination with standard pemetrexed (500 mg/m2 every 21 days).The primary objective of the Phase 2 portion of the study (estimated to begin enrollment in Sep-Nov 2006) is to assess the impact on progression-free survival of the combination of ABT-751 + pemetrexed compared to pemetrexed alone in subjects with NSCLC who have received at least one prior chemotherapy regimen.


Inclusion criteria

  • Advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following one or more chemotherapy regimens