Patients With Advanced or Metastatic Solid TumorsPhase 1NCT02867397
Study of Teysuno (S-1) Combined With Epirubicin and Oxaliplatin in Patients With Advanced Solid Tumors
A Phase 1 study testing Teysuno (S1) in combination with epirubicin and oxaliplatin in people with Patients With Advanced or Metastatic Solid Tumors, run by Disphar International B.V..
Trial summary
The goal of the current study was to investigate the safety and determine the maximum tolerated dose (MTD) of S-1 in combination with oxaliplatin and epirubicin in patients with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Advanced or Metastatic Solid Tumors
- What is being tested?
- Teysuno (S1) in combination with epirubicin and oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Aug 2015
- 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 years and older
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had given written informed consent.
- Was ≥18 years of age.
- Had advanced or metastatic solid tumor(s) for which no established curative therapy exists.
- Had received any number of prior therapies for advanced or metastatic disease.
- Was able to take medications orally.
- Had ECOG performance status 0 or 1 on Cycle 1, Day 1
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- Had a life expectancy of at least 3 months.
- Had LVEF ≥ the LLN for the institution.
- Had serum troponin T and CPK-MB values ≤ ULN for the institution.
- Had adequate organ function as defined by the following criteria:
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 x ULN; if liver function abnormalities were due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ≤5 x ULN.
- Total serum bilirubin of ≤1.5 x ULN.
- Absolute neutrophil count of ≥1,500/mm3 (ie, ≥1.5 x 109/L by International Units [IU]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor (G-CSF).
- Platelet count ≥100,000/mm3 (IU: ≥100 x 109/L) (excluding measurements obtained within 7 days after transfusion).
- Hemoglobin value of ≥9.0 g/dL (excluding measurements obtained within 7 days after transfusion).
- Creatinine clearance ≥60 mL/min based on calculated creatinine clearance or 24-hour urine collection.
- Was willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
Who cannot join
- Has had treatment with any of the following within the specified time frame prior to study drug administration:
- Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to study drug administration).
- Radiotherapy within prior 4 weeks.
- >25% of marrow-bearing bone radiated (Pre-Amendment 3).
- Any chemotherapy within prior 3 weeks.
- Previously received oxaliplatin or S-1.
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- Previously received epirubicin with cumulative dose >350 mg/m2 (patients who have received epirubicin with cumulative dose ≤350 mg/m2 as adjuvant therapy are allowed to enroll).
- Extensive prior exposure to other anthracycline or anthracenedione agents (ie, prior cumulative doxorubicin exposure of ≥450 mg/m2 or prior mitoxantrone exposure of >100 mg/m2)
- Received trastuzumab (cardiotoxic agent) within prior 24 weeks.
- Any investigational agent received either concurrently or within the last 30 days.
- Current enrollment in another interventional clinical study.
- Has a serious illness or medical condition(s) including, but not limited to, the following:
- Known brain metastasis or leptomeningeal metastasis.
- Known acute systemic infection.
- Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or deep vein thrombosis within the last 12 months.
- Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV (see Appendix E).
- Ongoing cardiac dysrhythmias (≥Grade 2), atrial fibrillation (any grade), or prolongation of QTc interval (>450 msec for males; >470 msec for females).
- Hypertensive crisis or severe hypertension that is not controlled.
- Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the Investigator.
- ≥Grade 1 peripheral neuropathy.
- Recent hemoptysis, coagulopathy and other bleeding disorders considered by the Investigator to be clinically significant.
- Known nephrotic syndrome (proteinuria >2 g/24 hours).
- Known clinically significant interstitial lung disease or pulmonary fibrosis.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
- Is receiving concomitant treatment with the following drugs that may interact with S-1:
- Sorivudine, brivudine, uracil, eniluracil, cimetidine, folinate/folinic acid, and dipyridamole (may enhance S-1 activity).
- Nitroimidazoles, including metronidazole and misonidazole (may enhance S-1 activity)
- Methotrexate (may enhance S-1 activity)
- Clozapine (may increase risk and severity of hematologic toxicity with S-1)
- Allopurinol (may diminish S-1 activity).
- Phenytoin (S-1 may enhance phenytoin activity).
- Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity).
- Is receiving concomitant treatment with the following drugs that may interaction with epirubicin:
- Cimetidine (may increase the area under the plasma concentration-time curve [AUC] of epirubicin).
- Dexverapamil (may alter the pharmacokinetics of epirubicin).
- Quinine (may accelerate the initial distribute on of epirubicin from blood into the tissues and may have an influence on the red blood cells partitioning of epirubicin).
- Interferon alfa-2b (may cause a reduction in both the terminal elimination half-life and the total clearance of epirubicin).
- Is a pregnant or lactating female.
- Has known hypersensitivity to 5-FU, epirubicin, oxaliplatin or other platinum compounds.
- Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients). Contraceptive measures must be taken by both male and female patients during and up to 6 months after stopping treatment with S-1.
About this study
Official title: A Phase 1, Open-Label, Non-Randomized, Dose-Finding, Safety and Tolerability Study of Orally Administered Teysuno (S-1) in Combination With Epirubicin and Oxaliplatin in Patients With Advanced Solid Tumors
The goal of the current study was to investigate the safety and determine the maximum tolerated dose (MTD) of S-1 in combination with oxaliplatin and epirubicin in patients with advanced or metastatic solid tumors.
- Being tested
- Teysuno (S1) in combination with epirubicin and oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teysuno (S1) in combination with epirubicin and oxaliplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Teysuno (S1) in combination with epirubicin and oxaliplatin | Other | Not described Receives: Drug: Teysuno (S1) in combination with epirubicin and oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The highest dose level at which less than 33% of the patients experienced a dose-limiting toxicity (DLT) during Cycle 1.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJan 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced or Metastatic 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Disphar International B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867397
- Sponsor's protocol ID
- TPU-S1119
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Non-Randomized, Dose-Finding, Safety and Tolerability Study of Orally Administered Teysuno (S-1) in Combination With Epirubicin and Oxaliplatin in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02867397
- Acronym / sponsor ID
- TPU-S1119
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Disphar International B.V.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Aug 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.
The goal of the current study was to investigate the safety and determine the maximum tolerated dose (MTD) of S-1 in combination with oxaliplatin and epirubicin in patients with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teysuno (S1) in combination with epirubicin and oxaliplatin | Other | Drug: Teysuno (S1) in combination with epirubicin and oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Had given written informed consent.
- Was ≥18 years of age.
- Had advanced or metastatic solid tumor(s) for which no established curative therapy exists.
- Had received any number of prior therapies for advanced or metastatic disease.
- Was able to take medications orally.
Key exclusion criteria (41 listed)
- Has had treatment with any of the following within the specified time frame prior to study drug administration:
- Has a serious illness or medical condition(s) including, but not limited to, the following:
- Is receiving concomitant treatment with the following drugs that may interact with S-1:
- Is receiving concomitant treatment with the following drugs that may interaction with epirubicin:
- Is a pregnant or lactating female.
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 |
|---|---|---|
| Teysuno (S1) in combination with epirubicin and oxaliplatin | Drug | Teysuno (S1) in combination with epirubicin and oxaliplatin |
Primary outcome
The highest dose level at which less than 33% of the patients experienced a dose-limiting toxicity (DLT) during Cycle 1.
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Teysuno (S1) in combination with epirubicin and oxaliplatin in people with Patients With Advanced or Metastatic Solid Tumors, run by Disphar International B.V..
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 17 inclusion and 41 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: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The highest dose level at which less than 33% of the patients experienced a dose-limiting toxicity (DLT) during Cycle 1. (time frame: 21 days). 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 15 Aug 2016.