Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
SC10914 is a potent selective PARP-1 and PARP-2 inhibitor. This study aims to determine the safety , tolerability , pharmacokinetic/pharmacodynamics profile of increasing doses of SC10914 when administered orally to patients with advanced solid tumors. Furthermore, the safety and efficacy of SC10914 in patients with advanced solid tumors and negative expression of ATM or BRCA1 or BRCA2 mutation will be evaluated in expanded cohorts to establish the Recommended Phase 2 Dose(RP2D).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC10914 | Experimental | SC10914 Dose Escalation: Dose Level 1:30mg(QD) Dose Level 2:60mg(QD) Dose Level 3:120mg(QD) Dose Level 4:200mg(QD) Dose Level 5:100mg(BID) Dose Level 6:300mg(QD) Dose Level 7:150mg(BID) Dose Level 8:400mg(QD) Dose Level 9:200mg(BID) Dose Expansion: Receiving SC10914 in one of three dosage regimens(low, middle or high dose-level and QD or BID) based on the assessment of dose escalation study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC10914 | Drug | SC10914 will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Study: Maximum-tolerated Dose (MTD) of SC10914 | In dose escalation study, SC10914 will be administered to patients with advanced solid tumors. MTD is defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) within 30 days after accepting SC10914. | 30 days |
| Dose Expansion Study: Recommended Phase II Dose(RP2D) of SC10914 | In dose expansion study,SC10914 will be administered to patients with advanced solid tumors and negative expression of ATM or BRCA1 or BRCA2 mutation.RP2D will be defined based on all available safety, pharmacokinetics(PK), pharmacodynamics(PD), and efficacy data collected after the start of SC10914 treatment. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events (AEs) as assessed by NCI-CTCAE v4.03 | 8 weeks | |
| Area under the concentration-time curve (AUC) | 4 weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maofu Luo | Contact | luomaofu@sh-qingfeng.net |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Time to reach maximum concentration (Tmax) |
| 4 weeks |
| Maximum Concentration (Cmax) | 4 weeks |
| Trough Concentration (Ctrough) | 4 weeks |
| Elimination Half-Life (T½) | 4 weeks |
| Clearance (CL) | 4 weeks |
| Volume of Distribution (Vd) | 4 weeks |
| Evaluation of the effects of PARP inhibition of SC10914 by the peripheral blood mononuclear cells(PBMC) | 8 weeks |
| Evaluation of the antitumor effects of SC10914 as measured by overall response rate (ORR) | 8 weeks |
| Evaluation of the antitumor effects of SC10914 as measured by disease control rate (DCR) | 8 weeks |
| Evaluation of the antitumor effects of SC10914 as measured by progression free survival (PFS) | 8 weeks |
| Evaluation of the antitumor effects of SC10914 as measured by duration of response (DOR) | 8 weeks |
| Evaluation of the antitumor effects of SC10914 as measured by time to progression (TTP) | 8 weeks |
| Evaluation of the antitumor effects of SC10914 as measured by overall survival (OS) | Baseline until death |
| Evaluation of the antitumor effects of SC10914 as measured by tumor markers CA-125 as assessed by Gynecologic Cancer Intergroup(GCIG) | 8 weeks |
| Evaluation of the antitumor effects of SC10914 as measured by tumor markers PSA as assessed by Prostate-Specific Antigen Working Group(PSAWG) | 8 weeks |