Safety Profile of CAP7.1 Obtained During Phase I Trial in Adult Patients with Refractory Malignancies

    January 2016 in “ Refubium (Universitätsbibliothek der Freien Universität Berlin) ”
    P. Mehlitz
    TLDR CAP7.1 is generally safe at 200 mg/m²/day, but can cause fatigue, nausea, hair loss, fever, and blood-related issues.
    The Phase I trial of CAP7.1, a prodrug of etoposide, involved 19 patients with refractory solid malignancies to assess its safety profile and determine the recommended phase II dose. Patients received doses ranging from 45 mg/m²/day to 200 mg/m²/day. The most common non-hematological adverse events were fatigue, nausea, alopecia, and fever, mostly grade 1 or 2. Hematological adverse events were dose-dependent, with neutropenic fever as the main dose-limiting toxicity. The maximum tolerated dose was between 150 and 200 mg/m²/day, and the recommended phase II dose was 200 mg/m²/day. The safety profile was similar to other topoisomerase inhibitors, with myelosuppression as the primary concern.
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