Advanced Solid TumorsPhase 1NCT02940132
A Study of SC10914 in Patients With Advanced Solid Tumors
A Phase 1 study testing SC10914 in people with Advanced Solid Tumors, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SC10914
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- With symptomatic brain metastases
- Pregnancy or lactation
- With Hepatitis B or C or human immunodeficiency virus infections
Trial locations and contacts
1 site in 1 country.
Maofu Luo contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Maofu Luo, luomaofu@sh-qingfeng.net
About this study
Official title: Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics and Preliminary Efficacy of SC10914 in Patients With Advanced Solid Tumors
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).
- Conditions
- Advanced Solid Tumors
- Being tested
- SC10914
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC10914Drug
SC10914 will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SC10914 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (17)
Number of participants with treatment-related adverse events (AEs) as assessed by NCI-CTCAE v4.03
Measured: 8 weeks
Area under the concentration-time curve (AUC)
Measured: 4 weeks
Time to reach maximum concentration (Tmax)
Measured: 4 weeks
Maximum Concentration (Cmax)
Measured: 4 weeks
Trough Concentration (Ctrough)
Measured: 4 weeks
Elimination Half-Life (T½)
Measured: 4 weeks
Clearance (CL)
Measured: 4 weeks
Volume of Distribution (Vd)
Measured: 4 weeks
Evaluation of the effects of PARP inhibition of SC10914 by the peripheral blood mononuclear cells（PBMC）
Measured: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by overall response rate (ORR)
Measured: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by disease control rate (DCR)
Measured: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by progression free survival (PFS)
Measured: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by duration of response (DOR)
Measured: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by time to progression (TTP)
Measured: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by overall survival (OS)
Measured: Baseline until death
Evaluation of the antitumor effects of SC10914 as measured by tumor markers CA-125 as assessed by Gynecologic Cancer Intergroup(GCIG)
Measured: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by tumor markers PSA as assessed by Prostate-Specific Antigen Working Group(PSAWG)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940132
- Sponsor's protocol ID
- QF-SC10914-011
- Status last verified
- Sep 2016
- First submitted
- 8 Oct 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics and Preliminary Efficacy of SC10914 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02940132
- Acronym / sponsor ID
- QF-SC10914-011
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SC10914 | Experimental | Drug: SC10914SC10914 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC10914SC10914 will be administered orally. | Drug | SC10914 |
Primary outcome
Dose Escalation Study: Maximum-tolerated Dose (MTD) of SC10914
Time frame: 30 days
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.
Dose Expansion Study: Recommended Phase II Dose(RP2D) of SC10914
Time frame: 8 weeks
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.
17 secondary outcomes
Number of participants with treatment-related adverse events (AEs) as assessed by NCI-CTCAE v4.03
Time frame: 8 weeks
Area under the concentration-time curve (AUC)
Time frame: 4 weeks
Time to reach maximum concentration (Tmax)
Time frame: 4 weeks
Maximum Concentration (Cmax)
Time frame: 4 weeks
Trough Concentration (Ctrough)
Time frame: 4 weeks
Elimination Half-Life (T½)
Time frame: 4 weeks
Clearance (CL)
Time frame: 4 weeks
Volume of Distribution (Vd)
Time frame: 4 weeks
Evaluation of the effects of PARP inhibition of SC10914 by the peripheral blood mononuclear cells（PBMC）
Time frame: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by overall response rate (ORR)
Time frame: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by disease control rate (DCR)
Time frame: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by progression free survival (PFS)
Time frame: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by duration of response (DOR)
Time frame: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by time to progression (TTP)
Time frame: 8 weeks
Evaluation of the antitumor effects of SC10914 as measured by overall survival (OS)
Time frame: Baseline until death
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maofu Luo contact
Lin Shen principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC10914 in people with Advanced Solid Tumors, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maofu Luo (luomaofu@sh-qingfeng.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Study: Maximum-tolerated Dose (MTD) of SC10914 (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.