Last updated on December 2015

A Study of rSIFN-co in Subjects With Advanced Solid Tumors


Brief description of study

This is a multicenter, open-label, phase I study of rSIFN-co (3 times a week via subcutaneous injection for 21 days, with 1 week of washout per cycle).

Detailed Study Description

The Dose-Escalation Cohort will consist of the Pretreatment Phase, the Treatment Phase, the Extension Phase, Discontinuation and Follow-up. The Pretreatment Phase will include a Consent and Screening Period. The Treatment Phase will consist of the Lead in Period and first 21-day cycle of treatment during which subjects will be monitored for the development of dose-limiting toxicity (DLT) following 1 week of washout. The Extension Phase will start from the start of Cycle 2 with intra-subject dose-escalation performed until discontinuation of study treatment. Upon discontinuation of study treatment, discontinuation visit assessments should occur within 7 days of treatment discontinuation or confirmation of discontinuation criteria. End of treatment information will also be collected for all subjects who discontinue treatment after completion of cycle 1 treatment. Follow-up visit/final visit evaluations will be performed 28 (±5 days) days after the last rSIFN-co administration. The decision to undergo dose-escalation to the next dose level will be based on the safety information obtained during Cycle 1. Dose escalation in solid tumors utilizing a "3+3" design with intra-subject dose escalation. 3 dose levels of rSIFN-co are planned for determining the RD. 3-6 subjects will be assigned to each dose level and followed up for 4 weeks after starting administration in Cycle 1. Each cohort will be started after the tolerability of that dose level has been confirmed in subjects with advanced solid tumors. For subjects starting in the lower dose cohorts, intra-subject dose escalation will be allowed till grade 3/4 toxicity is encountered or 24µg TIW is reached. In order to minimize the risk of allergic reactions, the sponsor has advised a lead-in period starting from 15µg. When the tolerability of each dose level has been confirmed by the observation of no DLT among 3 subjects, escalation to the next dose level will occur. The Expansion Cohort will be initiated at the RD. Depending on the RD, the lead in period will occur accordingly. After the lead in period, a period from Cycle 1 to the final administration will be performed as the Treatment Phase during which subjects will undergo a standardized evaluation for the safety and efficacy of rSIFN-co at the RD. If subjects are discontinued from the study treatment, discontinuation visit assessments should occur within 7 days of last rSIFN-co administration or confirmation of discontinuation criteria. End of treatment information will also be collected for all subjects who discontinue treatment after completion of cycle 1 treatment. Follow-up evaluations will be performed 28 days (±5 days) after the last rSIFN-co administration.

Clinical Study Identifier: NCT02387307

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Recruitment Status: Open


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