The 125 patients randomized to the trial were well-balanced for patient demographics and key ovarian cancer disease characteristics. Telcyta was administered at 1000 mg/m2 followed by PLD at 50 mg/m2, the approved dose of PLD, every 28 days. Thirty-five patients were not able to complete their assigned per-protocol therapy and discontinued due to the clinical hold, including 21 patients on the Telcyta plus PLD arm and 14 patients on the PLD control arm.
There was a higher incidence of hematologic adverse events (AEs) in patients on the Telcyta plus PLD arm (66%) versus 44% on the PLD arm. The hematologic toxicities were manageable with dose reductions and growth factor support on both treatment arms.
The most common, non-hematologic adverse events, including nausea, fatigue, vomiting, and constipation, were similar in incidence and severity on both arms. Seventeen percent Grade 2 and 3 stomatitis and 9% Grade 2 and 3 palmar-plantar erythrodysesthesia (PPE) were observed on the Telcyta plus PLD arm, compared to 23% Grade 2 and 3 stomatitis and 21% Grade 2 and 3 PPE on the PLD control arm. Grade 4 PPE (2%) was only observed on the PLD control arm. Telcyta may ameliorate the incidence and severity of stomatitis and PPE known to be associated with PLD.
The results will be presented at an upcoming scientific conference.
About Platinum Refractory and Resistant Ovarian Cancer
Platinum refractory or primary platinum-resistance is defined as those patients whose disease fails to respond or relapses within 6 months of completion of initial platinum-based treatment. Secondary platinum resistance is defined as those patients whose disease relapses after 6 months of completion of therapy and fails a reinduction platinum-based regimen.
Telik, Inc. of Palo Alto, CA, is a
|SOURCE Telik, Inc.|
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