Pancreatic CancerPhase 2NCT04571489
A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing Gimatecan, tegafur, gimeracil and oteracil potassium and gemcitabine in people with Pancreatic Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gimatecan, tegafur, gimeracil and oteracil potassium and gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed pancreatic cancer originating from pancreatic ductal epithelium, excluding pancreatic endocrine tumor;
- Locally advanced or metastatic pancreatic cancer in no condition for radical radiotherapy or operation;
- Failed in first-line gemcitabine or fluorouracil drugs chemotherapy (Recurrence within 6 months after treatment, progression or toxicity intolerance during treatment);
- Chemotherapy, targeted therapy or radical radiotherapy should be stopped 3 weeks ago, immunotherapy should be stopped 4 weeks ago, and previous toxicity recovered (CTCAE ≤ level 1);
- Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- No younger than 18 years old of either gender;
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- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
- Estimated life expectancy >3 months;
- The function of important organs meets the following requirements:
- absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 85×109/L, hemoglobin ≥ 90g/L;
- serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min, U-pro < 2+ or 1.0g/L; if U-pro ≥2+ or 1.0g/L, 24 hours U-pro ≤ 1.0g/L can be included;
- total bilirubin ≤ 1.5×ULN, obstructive jaundice with biliary drainage: total bilirubin ≤ 2.0×ULN; alanine transaminase and aspartate aminotransferase ≤ 2.5×ULN, liver metastasis ≤ 5.0×ULN; serum albumin ≥ 30g/L;
- Without a history of allergy or hypersensitivity to camptothecin drugs;
- Taking drugs orally;
- Serum human chorionic gonadotropin negative in premenopausal women; female patients of childbearing potential and male patients with female partners of childbearing potential must be willing to avoid pregnancy;
- Ability to understand the study and sign informed consent.
Who cannot join
- Patients who have been previously treated with camptothecin drugs or topoisomerase I inhibitor within 6 months before enrollment;
- Patients who have been previously treated with gemcitabine and fluorouracil in first-line treatment within 6 months before enrollment;
- Patients who have been previously treated with other investigational drugs within 4 weeks before enrollment;
- Patients with brain or meningeal metastasis;
- Patients with a history of gastrointestinal disease which affects drug absorption;
- Patients with serous cavity effusion with clinical symptoms (such as pleural effusion, peritoneal effusion, pericardial effusion, etc.), which continue to increase after two-week conservative treatment (excluding puncture drainage);
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- Patients with hypertension that cannot be controlled by drugs (≥ 160/100mmhg); angina pectoris within 3 months before enrollment or unstable angina pectoris; myocardial infarction within 1 year before enrollment and cardiac insufficiency (NYHA ≥ II);
- Patients with active infections requiring systemic treatment or pyrexia of unknown origin prior to initial administration (except neoplastic fever);
- Patients with hepatitis B surface antigen positive and peripheral blood hepatitis B virus DNA ≥1.0×103 copy/mL; positive of hepatitis C antibody and peripheral blood hepatitis C virus RNA;
- Patients with active pulmonary tuberculosis or uncontrolled pulmonary tuberculosis after anti-tuberculosis treatment;
- Patients with a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;
- Patients with a history of malignancies other than pancreatic cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or malignant tumors that have been cured for 5 years;
- Pregnant or lactating women;
- Patients with a history of mental diseases (including epilepsy or dementia).
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
WANG LIWEI, MD, 86-021-68383364
About this study
Official title: Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study
This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.
- Conditions
- Pancreatic Cancer
- Being tested
- Gimatecan, tegafur, gimeracil and oteracil potassium, gemcitabine
- Keywords
- Pancreatic Cancer, chemotherapy, gimatecan
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GimatecanDrug
Also called ST1481
Patients will receive gimatecan orally at 0.8mg/m2 on day 1-5 every 4 weeks.
tegafur, gimeracil and oteracil potassiumDrug
Patients will receive tegafur, gimeracil and oteracil potassium orally at 40 or 60mg twice daily on days 1 to 14 every 3 weeks.
gemcitabineDrug
Patients will receive gemcitabine IV at 1000mg/m2 on days 1、8 every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gimatecan group | Experimental | All patients will receive gimatecan (0.8mg/m2, on days 1 to 5, PO, every 4 weeks) until progressive disease (PD). Receives: Drug: Gimatecan |
| placebo group | Placebo comparator | All patients will receive tegafur, gimeracil and oteracil potassium (40-60mg, twice daily, on days 1 to 14 , PO, every 3 weeks) or gemcitabine (1000mg/m2, on days 1、8, IV, every 3 weeks) until progressive disease (PD). Receives: Drug: tegafur, gimeracil and oteracil potassium; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The 2-year progression free survival of the whole group.
Measured: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
Secondary outcomes (5)
Overall survival (OS)
The 2-year overall survival of the whole group.
Measured: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
Objective response rate (ORR)
Percentage of patients with objective response assessed by best overall.
Measured: To evaluate objective response rate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Duration of Response (DoR)
The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).
Measured: First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months.
Disease control rate (DCR)
Percentage of patients with disease control as assessed by best overall.
Measured: To evaluate disease control rate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Patient-reported outcome (PRO)
Change from baseline assessed according to the quality of life questionnaire C30.
Measured: To evaluate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- WANG LIWEI, MD, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571489
- Sponsor's protocol ID
- ST1481-LEES-2020-05
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.
PubMed 9196156Sessa C, Cresta S, Cerny T, Baselga J, Rota Caremoli E, Malossi A, Hess D, Trigo J, Zucchetti M, D'Incalci M, Zaniboni A, Capri G, Gatti B, Carminati P, Zanna C, Marsoni S, Gianni L. Concerted escalation of dose and dosing duration in a phase I study of the oral camptothecin gimatecan (ST1481) in patients with advanced solid tumors. Ann Oncol. 2007 Mar;18(3):561-8. doi: 10.1093/annonc/mdl418. Epub 2006 Dec 5.
PubMed 17150998Hu J, Wen PY, Abrey LE, Fadul CE, Drappatz J, Salem N, Supko JG, Hochberg F. A phase II trial of oral gimatecan for recurrent glioblastoma. J Neurooncol. 2013 Feb;111(3):347-53. doi: 10.1007/s11060-012-1023-0. Epub 2012 Dec 12.
PubMed 23232808Pecorelli S, Ray-Coquard I, Tredan O, Colombo N, Parma G, Tisi G, Katsaros D, Lhomme C, Lissoni AA, Vermorken JB, du Bois A, Poveda A, Frigerio L, Barbieri P, Carminati P, Brienza S, Guastalla JP. Phase II of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer, previously treated with platinum and taxanes. Ann Oncol. 2010 Apr;21(4):759-765. doi: 10.1093/annonc/mdp514. Epub 2009 Nov 11.
PubMed 19906760
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study
- ClinicalTrials.gov ID
- NCT04571489
- Acronym / sponsor ID
- ST1481-LEES-2020-05
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, chemotherapy, gimatecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 1 Oct 2020 (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 phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gimatecan group | Experimental | Drug: GimatecanAll patients will receive gimatecan (0.8mg/m2, on days 1 to 5, PO, every 4 weeks) until progressive disease (PD). |
| placebo group | Placebo comparator | Drug: tegafur, gimeracil and oteracil potassium, Drug: gemcitabineAll patients will receive tegafur, gimeracil and oteracil potassium (40-60mg, twice daily, on days 1 to 14 , PO, every 3 weeks) or gemcitabine (1000mg/m2, on days 1、8, IV, every 3 weeks) until progressive disease (PD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed pancreatic cancer originating from pancreatic ductal epithelium, excluding pancreatic endocrine tumor;
- Locally advanced or metastatic pancreatic cancer in no condition for radical radiotherapy or operation;
- Failed in first-line gemcitabine or fluorouracil drugs chemotherapy (Recurrence within 6 months after treatment, progression or toxicity intolerance during treatment);
- Chemotherapy, targeted therapy or radical radiotherapy should be stopped 3 weeks ago, immunotherapy should be stopped 4 weeks ago, and previous toxicity recovered (CTCAE ≤ level 1);
- Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
Key exclusion criteria (14 listed)
- Patients who have been previously treated with camptothecin drugs or topoisomerase I inhibitor within 6 months before enrollment;
- Patients who have been previously treated with gemcitabine and fluorouracil in first-line treatment within 6 months before enrollment;
- Patients who have been previously treated with other investigational drugs within 4 weeks before enrollment;
- Patients with brain or meningeal metastasis;
- Patients with a history of gastrointestinal disease which affects drug absorption;
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 |
|---|---|---|
| GimatecanAlso: ST1481Patients will receive gimatecan orally at 0.8mg/m2 on day 1-5 every 4 weeks. | Drug | Gimatecan group |
| tegafur, gimeracil and oteracil potassiumPatients will receive tegafur, gimeracil and oteracil potassium orally at 40 or 60mg twice daily on days 1 to 14 every 3 weeks. | Drug | placebo group |
| gemcitabinePatients will receive gemcitabine IV at 1000mg/m2 on days 1、8 every 3 weeks. | Drug | placebo group |
Primary outcome
Progression free survival (PFS)
Time frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
The 2-year progression free survival of the whole group.
5 secondary outcomes
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
Objective response rate (ORR)
Time frame: To evaluate objective response rate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Duration of Response (DoR)
Time frame: First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months.
Disease control rate (DCR)
Time frame: To evaluate disease control rate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Patient-reported outcome (PRO)
Time frame: To evaluate every 6 weeks after the initiation of chemotherapy, up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Background: PubMed 9196156Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.
- Background: PubMed 17150998Sessa C, Cresta S, Cerny T, Baselga J, Rota Caremoli E, Malossi A, Hess D, Trigo J, Zucchetti M, D'Incalci M, Zaniboni A, Capri G, Gatti B, Carminati P, Zanna C, Marsoni S, Gianni L. Concerted escalation of dose and dosing duration in a phase I study of the oral camptothecin gimatecan (ST1481) in patients with advanced solid tumors. Ann Oncol. 2007 Mar;18(3):561-8. doi: 10.1093/annonc/mdl418. Epub 2006 Dec 5.
- Background: PubMed 23232808Hu J, Wen PY, Abrey LE, Fadul CE, Drappatz J, Salem N, Supko JG, Hochberg F. A phase II trial of oral gimatecan for recurrent glioblastoma. J Neurooncol. 2013 Feb;111(3):347-53. doi: 10.1007/s11060-012-1023-0. Epub 2012 Dec 12.
- Background: PubMed 19906760Pecorelli S, Ray-Coquard I, Tredan O, Colombo N, Parma G, Tisi G, Katsaros D, Lhomme C, Lissoni AA, Vermorken JB, du Bois A, Poveda A, Frigerio L, Barbieri P, Carminati P, Brienza S, Guastalla JP. Phase II of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer, previously treated with platinum and taxanes. Ann Oncol. 2010 Apr;21(4):759-765. doi: 10.1093/annonc/mdp514. Epub 2009 Nov 11.
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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.
WANG LIWEI, MD study director
RenJi Hospital
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 Gimatecan, tegafur, gimeracil and oteracil potassium and gemcitabine in people with Pancreatic Cancer, run by Lee's Pharmaceutical Limited 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 16 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 1 Oct 2020. 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. Some participants in this study may receive a placebo. 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?
Contact WANG LIWEI, MD (86-021-68385559, lwwang2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571489, which also lists 4 linked publications.
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 1 Oct 2020.