Advanced Solid TumorPhase 1NCT04058587
A Phase I Trial of Simmitinib in Advanced Solid Tumors
A Phase 1 study testing Simmitinib in people with Advanced Solid Tumor, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Simmitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2020to 31 Mar 2023
- 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
- Voluntary written informed consent of the patient obtained before any study-specific procedure；
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to standard therapy or for whom no standard therapy exist;
- Adequate washing period from last anti-tumor therapy;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
- The expected survival time for more than 12 weeks;
- Adequate bone marrow, hepatic, renal, pancreas, and coagulation function, Blood phosphorus and calcium in the normal range.
Who cannot join
- Prior treatment with selective FGFR inhibitors or multi-target kinase Inhibitors with FGFR as the main target;
- Unrecovered from any drug-related adverse event to grade ≤ 1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0 derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects;
- Active Central Nervous System (CNS) metastases (brain or leptomeningeal metastases, etc.);
- Any other history of malignancy within 3 years;
- Congenital coagulation abnormalities. Active bleeding or previous history of massive bleeding (>30ml within 3 months), history of hemoptysis (more than 5ml fresh bleeding within 4 weeks);
- Corneal diseases of clinical significance. There is a history of retinal pigment epithelial detachment or evidence of the presence of retinal pigment epithelial detachment. History of age-related macular degeneration or evidence of age-related macular degeneration exists；
- Subjects with impaired cardiac function or heart disease of clinical significance;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Beijing
Wen Xu, 0311-67808817, xuwen@cspc.cn
Xiaowen Liu, 0311-67808817, liuxiaowen@cspc.cn
About this study
Official title: Phase I Dose-escalation Trial of Simmitinib for Patients With Advanced Solid Tumors in Therapeutic Failure
This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer.
Read the detailed description
This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer [including gastroesophageal cancer], cholangiocarcinoma, lung squamous cell carcinoma, urothelial transitional cell carcinoma, and estrogen-receptor-positive breast cancer patients [ER+], etc. This phase I study will evaluate the safety, tolerability, pharmacokinetics and the preliminary efficacy of the FGFR/KDR/CSF1R multi-target inhibitor Simmitinib.
- Conditions
- Advanced Solid Tumor
- Being tested
- Simmitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimmitinibDrug
Also called SOMCL-15-290
The core trial period includes 4-weeks Screening stage (28d), 7-days single administration stage, 4-weeks multiple administration stage (28d), 3-days blood collection stage of PK after multiple administration.
The starting dose was set at 1mg/d on toxicology data. Dosing will continue uninterrupted for 28 days in multiple administration stage.
The dose-limiting toxicity (DLT) period assessment will be from the first administration of Simmitinib tablet to the end of the first cycle (35 days).
| Study group | Role | What they receive |
|---|---|---|
| Simmitinib tablet | Experimental | The core trial period includes 4-weeks Screening stage (28d), 7-days single administration stage, 4-weeks multiple administration stage (28d), 3-days blood collection stage of PK after multiple administration.
The starting dose was set at 1mg/d on toxicology data. Dosing will continue uninterrupted for 28 days in multiple administration stage.
The dose-limiting toxicity (DLT) period assessment will be from the first administration of Simmitinib tablet to the end of the first cycle (35 days). Receives: Drug: Simmitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limited toxicity (DLT)
To identify the dose-limited toxicity (DLT).
Measured: 1 year
Maximum tolerated dose (MTD)
To identify the maximum tolerated dose (MTD).
Measured: 1 year
Recommended Phase II Dose (RP2D)
To identify the Recommended Phase II Dose (RP2D).
Measured: 1 year
Secondary outcomes (8)
Area under the plasma concentration versus time curve (AUC)
To preliminarily evaluate the AUC in patients with advanced solid tumors.
Measured: 2 year
Peak Plasma Concentration (Cmax)
To preliminarily evaluate Cmax in patients with advanced solid tumors.
Measured: 2 year
Time of peak plasma concentration (Tmax)
To preliminarily evaluate Tmax in patients with advanced solid tumors.
Measured: 2 year
Overall response rate (ORR)
To preliminarily evaluate ORR in patients with advanced solid tumors.
Measured: 2 year
Duration of Response (DoR)
To preliminarily evaluate DoR in patients with advanced solid tumors.
Measured: 2 year
Median progression free survival (PFS)
To preliminarily evaluate PFS in patients with advanced solid tumors.
Measured: 2 year
Median overall survival (OS)
To preliminarily evaluate OS in patients with advanced solid tumors.
Measured: 2 year
Gene status
FGFR1-4, VEGFA, CSF1, CSF1R and other related gene status
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start8 Jun 2020
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Runshi Pharmaceutical Technology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058587
- Sponsor's protocol ID
- SOMCL-15-290-201901
- Status last verified
- Jun 2022
- First submitted
- 6 Aug 2019
- Last updated
- 6 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-escalation Trial of Simmitinib for Patients With Advanced Solid Tumors in Therapeutic Failure
- ClinicalTrials.gov ID
- NCT04058587
- Acronym / sponsor ID
- SOMCL-15-290-201901
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Runshi Pharmaceutical Technology Co., Ltd
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 15 Aug 2019 (actual)
- 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.
This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer.
Detailed description
This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer [including gastroesophageal cancer], cholangiocarcinoma, lung squamous cell carcinoma, urothelial transitional cell carcinoma, and estrogen-receptor-positive breast cancer patients [ER+], etc. This phase I study will evaluate the safety, tolerability, pharmacokinetics and the preliminary efficacy of the FGFR/KDR/CSF1R multi-target inhibitor Simmitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simmitinib tablet | Experimental | Drug: SimmitinibThe core trial period includes 4-weeks Screening stage (28d), 7-days single administration stage, 4-weeks multiple administration stage (28d), 3-days blood collection stage of PK after multiple administration. The starting dose was set at 1mg/d on toxicology data. Dosing will continue uninterrupted for 28 days in multiple administration stage. The dose-limiting toxicity (DLT) period assessment will be from the first administration of Simmitinib tablet to the end of the first cycle (35 days). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary written informed consent of the patient obtained before any study-specific procedure；
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to standard therapy or for whom no standard therapy exist;
- Adequate washing period from last anti-tumor therapy;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
Key exclusion criteria (8 listed)
- Prior treatment with selective FGFR inhibitors or multi-target kinase Inhibitors with FGFR as the main target;
- Unrecovered from any drug-related adverse event to grade ≤ 1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0 derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects;
- Active Central Nervous System (CNS) metastases (brain or leptomeningeal metastases, etc.);
- Any other history of malignancy within 3 years;
- Congenital coagulation abnormalities. Active bleeding or previous history of massive bleeding (>30ml within 3 months), history of hemoptysis (more than 5ml fresh bleeding within 4 weeks);
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 |
|---|---|---|
| SimmitinibAlso: SOMCL-15-290The core trial period includes 4-weeks Screening stage (28d), 7-days single administration stage, 4-weeks multiple administration stage (28d), 3-days blood collection stage of PK after multiple administration. The starting dose was set at 1mg/d on toxicology data. Dosing will continue uninterrupted for 28 days in multiple administration stage. The dose-limiting toxicity (DLT) period assessment will be from the first administration of Simmitinib tablet to the end of the first cycle (35 days). | Drug | Simmitinib tablet |
Primary outcome
Dose-limited toxicity (DLT)
Time frame: 1 year
To identify the dose-limited toxicity (DLT).
Maximum tolerated dose (MTD)
Time frame: 1 year
To identify the maximum tolerated dose (MTD).
Recommended Phase II Dose (RP2D)
Time frame: 1 year
To identify the Recommended Phase II Dose (RP2D).
8 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: 2 year
Peak Plasma Concentration (Cmax)
Time frame: 2 year
Time of peak plasma concentration (Tmax)
Time frame: 2 year
Overall response rate (ORR)
Time frame: 2 year
Duration of Response (DoR)
Time frame: 2 year
Median progression free survival (PFS)
Time frame: 2 year
Median overall survival (OS)
Time frame: 2 year
Gene status
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
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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.
Yuankai Shi principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Simmitinib in people with Advanced Solid Tumor, run by CSPC ZhongQi Pharmaceutical Technology 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 8 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 Jun 2022. 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 Wen Xu (0311-67808817, xuwen@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limited toxicity (DLT) (time frame: 1 year). The study lists 3 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 Jun 2022.