This rollover protocol allows continued access to seclidemstat (SP-2577) for patients who are still receiving clinical benefit on completed or closed Salarius sponsored studies.
The population for the rollover study should be consistent with the population defined in the parent study. The primary eligibility criteria for a patient to enter the rollover protocol is the participation and completion of a Salarius sponsored study with seclidemstat. Safety data and an evaluation of anti-tumor activity will be collected. Patients who have completed a prior study with seclidemstat and who are assessed by the Investigator to continue to benefit from ongoing treatment will be eligible.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Treatment assigned as per parent protocol
Sarcoma Oncology Center
Santa Monica, California, United States
Length of time receiving study treatment
Length of time receiving treatment with seclidemstat as single agent or in combination with assigned parent protocol therapy
Time frame: months on study where patients continue to receive clinical benefit, up to 5 years
Number of patients enrolled through study completion
Number of patients enrolled who received seclidemstat
Time frame: Number of patients enrolled on study who continue to receive clinical benefit, up to 5 years
Evaluate safety & tolerability utilizing the most current version of CTCAE
Evaluate the safety and tolerability of seclidemstat by characterizing adverse events according to the most current version of CTCAE
Time frame: During treatment while on study and continuing to receive clinical benefit, up to 5 years
Evaluate anti-tumor activity based upon imaging studies according to RECIST v1.1
Evaluate the anti-tumor activity of seclidemstat based upon imaging studies according to RECIST v1.1
Time frame: During treatment while on study and continuing to receive clinical benefit, up to 5 years
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