A Study of SC10914 in Patients With Advanced Solid Tumors

Qingfeng Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: SC10914

Study type: Interventional

Funder types: Industry

Identifiers

NCT02940132

QF-SC10914-011

Details and patient eligibility

About

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).

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

SC10914

Experimental group

Description:

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.

Treatment:

Drug: SC10914