Recurrent and Metastatic Gastric CancerPhase 1NCT03026881
A Study of Fluzoparib Given in Combination With Apatinib and Paclitaxel in Gastric Cancer Patients
A Phase 1 study testing Fluzoparib, Apatinib and Paclitaxel in people with Recurrent and Metastatic Gastric Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent and Metastatic Gastric Cancer
- What is being tested?
- Fluzoparib, Apatinib and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jun 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
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- Histologically or cytologically confirmed gastric adenocarcinoma( adenocarcinoma of the gastroesophageal junction included).
- Recurrent or metastatic gastric cancer that has progressed following first line-therapy.
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline
- Subjects who have overall good overall general condition.
- Signed informed consent.
Who cannot join
- Subjects who received any previous treatment with any PARP inhibitors.
- Subjects who received any previous treatment with any taxanes.
- More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
- Less than 4 weeks from the last clinical trial.
- Less than 2 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
- Unstable hypertension.
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- Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
- Subjects with brain metastases.
- Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
- Subjects with a known hypersensitivity to fluzoparib, apatinib, paclitaxel or any of the excipients of the product.
- Ongoing infection (determined by investigator).
- History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
Jianming Xu, MD contact
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Military Medical Sciences
Beijing, Beijing Municipality, 100039
Jianming Xu, MD, jmxu2003@yahoo.com
About this study
Official title: An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib and Paclitaxel in the 2nd Line Treatment of Patients With Recurrent or Metastatic Gastric Cancer
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the treatment of patients with recurrent and metastatic gastric cancer who progress following first-line therapy. The safety and efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.
- Conditions
- Recurrent and Metastatic Gastric Cancer
- Being tested
- Fluzoparib, Apatinib, Paclitaxel
- Keywords
- PARP inhibitor, VEGFR inhibitor, Combination therapy, Gastric cancer
- Medical subject headings
- Recurrence, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
Also called SHR3162
Fluzoparib either at 20,30,40mg twice daily,capsule oral.
ApatinibDrug
Oral
PaclitaxelDrug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib + Apatinib + Paclitaxel | Experimental | Not described Receives: Drug: Fluzoparib; Drug: Apatinib; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.
DLT and safety defined by CTC version 4.0
Measured: through study completion, an average of 6 months
Secondary outcomes (10)
Best of ORR
Measured: through study completion, an average of 6 months
Overall Response Rate (ORR)
Measured: through study completion, an average of 6 months
Disease Control Rate (DOR)
Measured: through study completion, an average of 6 months
Time to Progression (TTP)
Measured: From date of enrollment until the date of first objective progression, assessed up to 9 months
Progression Free Survival (PFS)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months
Maximum plasma concentration (Cmax)
Measured: Up to 33 days
Terminal half life (t1/2)
Measured: Up to 33 days
Area under the plasma concentration-time curve (AUC）
Measured: Up to 33 days
Volume of distribution (V/F)
Measured: Up to 33 days
Plasma Clearance (CL/F)
Measured: Up to 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionApr 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent and Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026881
- Sponsor's protocol ID
- FZPL-I-103-GC
- Status last verified
- Mar 2017
- First submitted
- 21 Dec 2016
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib and Paclitaxel in the 2nd Line Treatment of Patients With Recurrent or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT03026881
- Acronym / sponsor ID
- FZPL-I-103-GC
- Conditions
- Recurrent and Metastatic Gastric Cancer
- Keywords
- PARP inhibitor, VEGFR inhibitor, Combination therapy, Gastric cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Study start
- Jan 2017
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 20 Jan 2017 (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.
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the treatment of patients with recurrent and metastatic gastric cancer who progress following first-line therapy. The safety and efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib + Apatinib + Paclitaxel | Experimental | Drug: Fluzoparib, Drug: Apatinib, Drug: Paclitaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- Histologically or cytologically confirmed gastric adenocarcinoma( adenocarcinoma of the gastroesophageal junction included).
- Recurrent or metastatic gastric cancer that has progressed following first line-therapy.
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline
Key exclusion criteria (14 listed)
- Subjects who received any previous treatment with any PARP inhibitors.
- Subjects who received any previous treatment with any taxanes.
- More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.
- Less than 4 weeks from the last clinical trial.
- Less than 2 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
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 |
|---|---|---|
| FluzoparibAlso: SHR3162Fluzoparib either at 20,30,40mg twice daily,capsule oral. | Drug | Fluzoparib + Apatinib + Paclitaxel |
| ApatinibOral | Drug | Fluzoparib + Apatinib + Paclitaxel |
| PaclitaxelIntravenous injection | Drug | Fluzoparib + Apatinib + Paclitaxel |
Primary outcome
DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.
Time frame: through study completion, an average of 6 months
DLT and safety defined by CTC version 4.0
10 secondary outcomes
Best of ORR
Time frame: through study completion, an average of 6 months
Overall Response Rate (ORR)
Time frame: through study completion, an average of 6 months
Disease Control Rate (DOR)
Time frame: through study completion, an average of 6 months
Time to Progression (TTP)
Time frame: From date of enrollment until the date of first objective progression, assessed up to 9 months
Progression Free Survival (PFS)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months
Maximum plasma concentration (Cmax)
Time frame: Up to 33 days
Terminal half life (t1/2)
Time frame: Up to 33 days
Area under the plasma concentration-time curve (AUC）
Time frame: Up to 33 days
Volume of distribution (V/F)
Time frame: Up to 33 days
Plasma Clearance (CL/F)
Time frame: Up to 33 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jianming Xu, MD contact
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 Fluzoparib, Apatinib and Paclitaxel in people with Recurrent and Metastatic Gastric Cancer, run by Jiangsu HengRui Medicine 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 14 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 7 Mar 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 Jianming Xu, MD (jmxu2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis. (time frame: through study completion, an average of 6 months). 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 7 Mar 2017.