Abstract
6623 Background: Dinaciclib is a potent and selective inhibitor of CDKs 1, 2, 5, and 9, with anti-CLL activity in ex vivo assays. Methods: Phase 1 trial to determine the recommended phase 2 dose (RPTD) of dinaciclib in CLL pts as a 2-hour IV infusion on days 1, 8 and 15 of a 28-day cycle. The 5 mg/m2 starting dose is based on significant CLL cell kill in preclinical assays. Results: 33 pts treated in 5 dose cohorts (5, 7, 10, 14 and 17 mg/m2). RPTD is 14 mg/m2. Median age is 62 (43-79) yrs, 42% ≥65 yrs, 67% Rai stage 3 or 4, 64% bulky disease, and 45% del 17p. Median # of prior therapies is 4 (1-12). 91% received fludarabine. 36% received flavopiridol. Median # of treatment cycles given is 5 (1-16). 9 pts received 6-8 cycles. 5 pts received 10-16 cycles. 15 partial responses (PR) by 1996 NCI-WG CLL criteria, with 4 pts proceeding to allogeneic SCT. Responders included 7 pts >65 yrs, 9 bulky disease, 14 prior fludarabine, and 5 prior flavopiridol. PR in 62.5% of pts (10/16) at the RPTD. PR in 47% of del 17...
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