Phase I/II Study of PCI-24781 in Combination With Doxorubicin for Treatment of Advanced Sarcomas Following Failure or Prior Anthracycline Therapy
- In the phase I portion of the study, since we are looking for the highest dose of
PCI-24781 that can be administered safely without severe or unmanageable side effects
in participants that have advanced sarcoma, not everyone who participates in this
research study will receive the same dose of PCI-24871.
- Each treatment cycle is 3 weeks (21 days). Participants will take capsules of
PCI-24871 for five consecutive days starting on Day 1 of each 3 week cycle. On Day 4
of each cycle, participants will come to the clinic to receive doxorubicin
- At specific time intervals, participants will return to the clinic for the following
tests and procedures: physical examination, vital signs, blood tests, urine test, EKG,
assessment of the tumor by CT scan, and an ECHO or MUGA.
- Participants may remain on the study for a maximum of 6 cycles (about 4-5 months).
After the last cycle, as long as the participant is showing benefit, they may elect to
continue taking PCI-24781 alone, in which case they will continue in this research
study until there is evidence of their tumor growing.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: To determine the MTD (and/or recommended phase II dose) of PCI-24781 when given orally twice a daily for 5 days in combination with doxorubicin.
Edwin Choy, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|