Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II)
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined
with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid
malignancy that is metastatic or unresectable and for which standard curative or palliative
measures do not exist or are no longer effective or would otherwise be eligible for cisplatin
and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined
based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet
combination will be assessed during the phase I part of the trial.
The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at
the MTD determined in the phase I part) in previously untreated, unresectable malignant
pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed,
cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be
stratified according to histology and performance status.