NCT02940132

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

December 6, 2017

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

October 8, 2016

Last Update Submit

December 4, 2017

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (17)

  • 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

  • Time to reach maximum concentration (Tmax)

    4 weeks

  • Maximum Concentration (Cmax)

    4 weeks

  • Trough Concentration (Ctrough)

    4 weeks

  • +12 more secondary outcomes

Study Arms (1)

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.

Drug: SC10914

Interventions

SC10914DRUG

SC10914 will be administered orally.

SC10914

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Study Officials

  • Lin Shen

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maofu Luo

CONTACT

luomaofu@sh-qingfeng.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2016

First Posted

October 20, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

December 6, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Locations

CN(1)