The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors.
This study is a Phase I/II, open-label, multicentre study of ACE-86225106 administered orally in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
298
ACE-86225106 will be administered orally daily as a continuous regimen. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)
Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination, etc.
Time frame: From time of information consent to 30 days post last dose, up to 3 years
The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol
A DLT is defined as any toxicity events related to ACE-86225106 that occur from the first dose of study treatment until the planned end date of Cycle 1 (DLT assessment period), meeting the criteria specified in protocol.
Time frame: From the first dose of ACE-86225106 on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (at the end of 28 days)
Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD)
RP2D will be finally determined by the Safety Monitoring Committee (SMC) and sponsor based on all data from the dose escalation module and backfill module, as well as the exposure-response relationship evaluated (if available). MTD is defined as the maximum dose level at which ≤1 patient have DLTs during the DLT observation period, and it should be determined with 6 evaluable patients.
Time frame: Up to 3 years
Objective Response Rate (ORR)
ORR is defined as proportion of patients who achieved complete response (CR) or partial response (PR) according to RECIST 1.1 recorded from first investigational product treatment until disease progression or death due to any cause. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks. For castration-resistant prostate cancer (CRPC) patients, bone lesion will be assessed according to PCWG3 criteria.
Time frame: Up to 3 years
Duration of Response (DoR) and Time to Response (TTR)
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGAnyang Cancer Hospital
Anyang, Henan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGHubei Cancer Hospital
Wuhan, Hubei, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGJinan Central Hospital
Jinan, Shandong, China
RECRUITINGQilu Hospital Shangdong University
Jinan, Shandong, China
RECRUITING...and 4 more locations
DOR is defined, for patients with an objective response, as the time from first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause.
Time frame: Up to 3 years
Progression Free Survival (PFS)
PFS is defined as the time from the first study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause.
Time frame: Up to 3 years
Overall Survival (OS)
OS is defined as the time from the first study treatment to the date of death due to any cause
Time frame: Up to 3 years
Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change
Blood drug concentrations at each scheduled time point will be summarized descriptively, and individual and mean concentration-time curves will be plotted by dose group.
Time frame: Up to 3 years
Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators)
The tests for the above serum tumor markers will support the tumor response evaluation.
Time frame: Up to 3 years