MedDataX Logo

A Study of SC10914 in Patients With Advanced Solid Tumors

NCT ID: NCT02940132

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SC10914

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.

Group Type EXPERIMENTAL

SC10914

Intervention Type DRUG

SC10914 will be administered orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SC10914

SC10914 will be administered orally.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lin Shen

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maofu Luo

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Maofu Luo

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QF-SC10914-011

Identifier Type: -

Identifier Source: org_study_id