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About
The purpose of this study was to establish the recommended phase 2 dose (RP2D) of ASP1650 (Safety Lead-in Phase), as well as, evaluate the efficacy of ASP1650 as measured by confirmed objective response rate (ORR) (phase 2) in participants with incurable platinum refractory germ cell tumors.
This study also evaluated the following efficacy measures for confirmed objective response rate (ORR); clinical benefit rate (CBR); duration of response (DOR); and progression-free survival (PFS); as well as safety and tolerability; the effect of ASP1650 on changes in serum beta human chorionic gonadotropin (βhCG) and alpha-fetoprotein (AFP); and the pharmacokinetics of ASP1650.
Full description
The study consisted of 2 phases: Safety Lead-in phase and phase 2. 19 participants were enrolled in both phases.
The Safety Lead-in phase of this study was to establish the tolerability of RP2D. The RP2D determination was based on at least 6 evaluable participants at the RP2D as determined by the Dose Evaluation Committee (DEC).
Once RP2D had been established as tolerable, 13 additional participants were enrolled in phase 2 to receive ASP1650 for up to a maximum of 12 cycles or until a study discontinuation criteria had been met, whichever occurred earlier.
Enrollment
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Inclusion criteria
Disease Specific Criteria:
Subject has histological evidence of germ cell tumor.
Subject must have a germ cell tumor that is not amenable to cure with either surgery or chemotherapy.
Subjects with seminoma and non-seminoma are eligible.
Subject must have received initial cisplatin based combination chemotherapy AND demonstrated progression following at least 1 salvage regimen for advanced germ cell neoplasm (including relapsed primary mediastinal nonseminomatous germ cell tumor).
Subjects with late relapse (> 2 years) not amenable to resection are eligible.
Subjects must have evidence of recurrent or metastatic carcinoma by 1 or more of the following:
Physical or Laboratory Findings:
Subject must have an available tumor specimen in a tissue block or unstained serial slides, or subject is an appropriate candidate for tumor biopsy and is amenable to undergoing a tumor biopsy during the screening period.
Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Subject must meet all of the following criteria based on the centrally analyzed laboratory tests within 14 days prior to the first dose of study treatment. If repeat screening labs are required, local laboratory results can be used to confirm eligibility. In case of multiple central laboratory data within this period, the most recent data should be used to determine eligibility.
Exclusion criteria
Prohibited Treatment or Therapies:
Medical History or Concurrent Disease:
Primary purpose
Allocation
Interventional model
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19 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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