Metastatic Pancreatic CancerPhase 2NCT05138159
A Study of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen
A Phase 2 study testing Donafenib and S1 in people with Metastatic Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of donafenib combined with S-1 in treating Patients with metastatic pancreatic cancer after chemotherapy with Nab-paclitaxel plus gemcitabine regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Donafenib and S1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Jul 2023
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent and willing to complete the study according to the protocol.
- Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender
- ECOG performance scale 0-1;
- Diagnosed as pancreatic adenocarcinoma by histology and cytology;
- Treatment of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen(The disease progresses during the course of treatment or within 6 months after the end of treatment, with clear imaging evidence; this does not include patients with intolerable toxicity)；
- Baseline blood routine and biochemical indexes meet the following criteria:
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- Blood routine examination criteria must be met: (no blood transfusion within 14 days)
- HB≥90g/L；
- ANC≥1.5×109/L；
- PLT≥100×109/L.
- Biochemical tests are subject to the following criteria:
- BIL <1.25xULN ；
- ALT and AST<2.5ULN；
- Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance>60ml/min ( Cockcroft-Gault formula).
- Albumin≥28g/L.
- Blood coagulation indexes are subject to the following criteria:
- Prothrombin time (PT) and international normalized ratio (INR) ≤1.5 × ULN;
- Activated partial thromboplastin time（APTT）≤1.5 × ULN.
- According to the standard of RECIST 1.1, there is at least one imaging measurable lesion;
- Life expectancy ≥ 3 months;
- Patients and their families were willing to cooperate with follow-up.
Who cannot join
- Diagnosis of malignant diseases other than pancreatic cancer within 5 years prior to first administration (excluding cured skin basal cell carcinoma, squamous carcinoma of the skin, and/or resected carcinoma in situ);
- Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
- Patients with brain metastases or pial metastases;
- Patients with a clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
- Comorbidities (e.g., severe or uncontrolled hypertension, severe diabetes, and/or thyroid disease) that, in the investigator's judgment, seriously endanger patients' safety or prevent them from completing the study;
- The patient was currently participating in an interventional clinical study or had been treated with another study drug or study device in the 4 weeks prior to initial dosing;
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- The patient had a history of organ transplantation;
- Concurrent administration of drugs that may prolong QTc and/or induce Tdp;
- Patients also take drugs that affect drug metabolism;
- HIV infection or acute or chronic viral hepatitis (hbSAG positive, HBV-DNA load ≥500IU/ml and/or HCV antibody positive);
- Excluded patients with serious cardiovascular disease, including grade ≥II cardiac dysfunction (NYHA criteria);
- Patients with severe gastrointestinal dysfunction (bleeding, infection, obstruction, or diarrhea greater than grade 1) were excluded;
- Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy were excluded;
- Patients with a severe arterial thromboembolism event within 6 months were excluded;
- Excluding women who are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University
Shanghai
Yu Xian-Jun, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org
About this study
Official title: A Prospective, Phase II, Single-arm Study to Evaluate The Safety and Efficacy of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen
This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of donafenib combined with S-1 in treating Patients with metastatic pancreatic cancer after chemotherapy with Nab-paclitaxel plus gemcitabine regimen.
Read the detailed description
While NG ( Nab-paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after NG regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received donafenib and S-1. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic.
The efficacy and safety data will be assessed through OS, ORR, DCR, PFS,TTP and adverse effects as graded by NCI CTC-AE 5.0.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Donafenib, S1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonafenibDrug
Donafenib: 200mg po bid.
S1Drug
S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Donafenib + S-1 | Experimental | Donafenib: 200mg po bid； S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle. Receives: Drug: Donafenib; Drug: S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
To evaluate the overall survival of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib combined with S-1.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Progression Free Survival
To investigate the progression-free survival (PFS) of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib combined with S-1.
Measured: through study completion, an average of 1 year
Overall Response Rate
To evaluate the overall response rate of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib combined with S-1.
Measured: through study completion, an average of 1 year
Incidence of Adverse Events
Adverse events of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib plus S-1.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138159
- Sponsor's protocol ID
- PDAC-ZPS-S
- Status last verified
- Oct 2021
- First submitted
- 17 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II, Single-arm Study to Evaluate The Safety and Efficacy of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen
- ClinicalTrials.gov ID
- NCT05138159
- Acronym / sponsor ID
- PDAC-ZPS-S
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 30 Nov 2021 (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 a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of donafenib combined with S-1 in treating Patients with metastatic pancreatic cancer after chemotherapy with Nab-paclitaxel plus gemcitabine regimen.
Detailed description
While NG ( Nab-paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after NG regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received donafenib and S-1. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic.
The efficacy and safety data will be assessed through OS, ORR, DCR, PFS,TTP and adverse effects as graded by NCI CTC-AE 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Donafenib + S-1 | Experimental | Drug: Donafenib, Drug: S1Donafenib: 200mg po bid； S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Informed consent and willing to complete the study according to the protocol.
- Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender
- ECOG performance scale 0-1;
- Diagnosed as pancreatic adenocarcinoma by histology and cytology;
- Treatment of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen(The disease progresses during the course of treatment or within 6 months after the end of treatment, with clear imaging evidence; this does not include patients with intolerable toxicity)；
Key exclusion criteria (15 listed)
- Diagnosis of malignant diseases other than pancreatic cancer within 5 years prior to first administration (excluding cured skin basal cell carcinoma, squamous carcinoma of the skin, and/or resected carcinoma in situ);
- Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
- Patients with brain metastases or pial metastases;
- Patients with a clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
- Comorbidities (e.g., severe or uncontrolled hypertension, severe diabetes, and/or thyroid disease) that, in the investigator's judgment, seriously endanger patients' safety or prevent them from completing the study;
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 |
|---|---|---|
| DonafenibDonafenib: 200mg po bid. | Drug | Experimental: Donafenib + S-1 |
| S1S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle. | Drug | Experimental: Donafenib + S-1 |
Primary outcome
Overall Survival
Time frame: through study completion, an average of 1 year
To evaluate the overall survival of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib combined with S-1.
3 secondary outcomes
Progression Free Survival
Time frame: through study completion, an average of 1 year
Overall Response Rate
Time frame: through study completion, an average of 1 year
Incidence of Adverse Events
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donafenib and S1 in people with Metastatic Pancreatic Cancer, run by Fudan University 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 21 inclusion and 15 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 30 Nov 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: through study completion, an average of 1 year). 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 30 Nov 2021.