A Study of SC10914 in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics and Preliminary Efficacy of SC10914 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02940132
• Other study ID #: QF-SC10914-011
• Status: Recruiting
• Phase: Phase 1
• First received: October 8, 2016
• Last updated: December 4, 2017
• Start date: October 2016
• Est. completion date: May 2018

Study information

• Verified date: September 2016
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: Maofu Luo
• Email: luomaofu[@]sh-qingfeng.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent

• Aged 18-70 years

• Dose escalation study: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists/Dose Expansion study: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists and negative expression of ATM or BRCA1 or BRCA2 mutation

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Have measurable lesion exists(RECIST 1.1)

• Life expectancy=3 months

• Have adequate bone marrow, hepatic and renal functions

Exclusion Criteria:

• Allergic constitution or hypersensitivity to investigational drugs or relevant drug

• Patients who received any previous treatment with a PARP inhibitor

• Patients accepted anti-cancer therapy including chemotherapy, radiotherapy, endocrinotherapy, immunotherapy, Chinese herbal treatment or other investigational drugs within 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea)

• With serious pre-existing medical conditions, such as significant cardiovascular disease and psychogenic disorders

• With family history of long QT syndrome or QTc = 450 ms

• With persistent CTCAE ?grade 2 toxicities (excluding alopecia) caused by prior medication

• With symptomatic brain metastases

• Pregnancy or lactation

• With Hepatitis B or C or human immunodeficiency virus infections

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• SC10914
SC10914 will be administered orally.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Number of participants with treatment-related adverse events (AEs) as assessed by NCI-CTCAE v4.03		8 weeks
Secondary	Area under the concentration-time curve (AUC)		4 weeks
Secondary	Time to reach maximum concentration (Tmax)		4 weeks
Secondary	Maximum Concentration (Cmax)		4 weeks
Secondary	Trough Concentration (Ctrough)		4 weeks
Secondary	Elimination Half-Life (T½)		4 weeks
Secondary	Clearance (CL)		4 weeks
Secondary	Volume of Distribution (Vd)		4 weeks
Secondary	Evaluation of the effects of PARP inhibition of SC10914 by the peripheral blood mononuclear cells(PBMC)		8 weeks
Secondary	Evaluation of the antitumor effects of SC10914 as measured by overall response rate (ORR)		8 weeks
Secondary	Evaluation of the antitumor effects of SC10914 as measured by disease control rate (DCR)		8 weeks
Secondary	Evaluation of the antitumor effects of SC10914 as measured by progression free survival (PFS)		8 weeks
Secondary	Evaluation of the antitumor effects of SC10914 as measured by duration of response (DOR)		8 weeks
Secondary	Evaluation of the antitumor effects of SC10914 as measured by time to progression (TTP)		8 weeks
Secondary	Evaluation of the antitumor effects of SC10914 as measured by overall survival (OS)		Baseline until death
Secondary	Evaluation of the antitumor effects of SC10914 as measured by tumor markers CA-125 as assessed by Gynecologic Cancer Intergroup(GCIG)		8 weeks
Secondary	Evaluation of the antitumor effects of SC10914 as measured by tumor markers PSA as assessed by Prostate-Specific Antigen Working Group(PSAWG)		8 weeks