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Status unknownNCT02940132Updated Dec 6, 2017

A Study of SC10914 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of SC10914 in Advanced Solid Tumors, sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-12-06.

Sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

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Conditions studied

  • Advanced Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 72 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.

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Lead sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd. is the lead sponsor of 32 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: SC10914

Interventions

  • DrugSC10914

    SC10914 will be administered orally.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

  2. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. Number of participants with treatment-related adverse events (AEs) as assessed by NCI-CTCAE v4.03

    Time frame: 8 weeks

  2. Area under the concentration-time curve (AUC)

    Time frame: 4 weeks

  3. Time to reach maximum concentration (Tmax)

    Time frame: 4 weeks

  4. Maximum Concentration (Cmax)

    Time frame: 4 weeks

  5. Trough Concentration (Ctrough)

    Time frame: 4 weeks

  6. Elimination Half-Life (T½)

    Time frame: 4 weeks

  7. Clearance (CL)

    Time frame: 4 weeks

  8. Volume of Distribution (Vd)

    Time frame: 4 weeks

  9. Evaluation of the effects of PARP inhibition of SC10914 by the peripheral blood mononuclear cells（PBMC）

    Time frame: 8 weeks

  10. Evaluation of the antitumor effects of SC10914 as measured by overall response rate (ORR)

    Time frame: 8 weeks

  11. Evaluation of the antitumor effects of SC10914 as measured by disease control rate (DCR)

    Time frame: 8 weeks

  12. Evaluation of the antitumor effects of SC10914 as measured by progression free survival (PFS)

    Time frame: 8 weeks

  13. Evaluation of the antitumor effects of SC10914 as measured by duration of response (DOR)

    Time frame: 8 weeks

  14. Evaluation of the antitumor effects of SC10914 as measured by time to progression (TTP)

    Time frame: 8 weeks

  15. Evaluation of the antitumor effects of SC10914 as measured by overall survival (OS)

    Time frame: Baseline until death

  16. Evaluation of the antitumor effects of SC10914 as measured by tumor markers CA-125 as assessed by Gynecologic Cancer Intergroup(GCIG)

    Time frame: 8 weeks

  17. Evaluation of the antitumor effects of SC10914 as measured by tumor markers PSA as assessed by Prostate-Specific Antigen Working Group(PSAWG)

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02940132
Lead sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Responsible party
Sponsor
First posted
Oct 20, 2016
Start date
Oct 2016
Primary completion
Mar 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Dec 6, 2017

Study contacts

Maofu Luo
Contact
luomaofu@sh-qingfeng.net
Lin Shen
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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