Gastric AdenocarcinomaPhase 1NCT04074343
TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma
A Phase 1 study testing TAS-102 and Irinotecan in people with Gastric Adenocarcinoma and GastroEsophageal Cancer, run by University of California, Irvine at 2 sites in United States.
Trial summary
This is a phase Ib single-arm, open-label clinical trial determining the feasibility and efficacy of TAS-102 and irinotecan in subjects with advanced gastric and gastroesophageal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, GastroEsophageal Cancer
- What is being tested?
- TAS-102 and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2019to 21 Jul 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically or cytologically confirmed gastric or gastroesophageal adenocarcinoma
- Must have locally advanced, recurrent, or metastatic disease not amenable to curative intent surgery.
- Must have progressed, or not tolerated, at least one line of treatment with a platinum and/or fluoropyrimidine containing regimen. At least one cycle of combination chemotherapy including a platinum (oxaliplatin, cisplatin, carboplatin) and/or fluoropyrimidine (capecitabine or 5-Fluorouracil) based regimen for advanced disease. Combination regimens with platinum/fluoropyrimidine containing a taxane and or a checkpoint inhibitor are allowed. Patients progressing within six months of perioperative chemotherapy or definitive chemoradiation for localized disease are eligible. Patients who have exhausted all other standard of care options are also eligible.
- Age ≥ 18 years
- Performance status: ECOG performance status ≤2
- Life expectancy of greater than 3 months
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- Adequate organ and marrow function as defined below:
- leukocytes : ≥ 3,000/mcL
- absolute neutrophil count: ≥ 1,500/mcL
- platelets: ≥ 80,000/mcl
- total bilirubin: within normal institutional limits
- AST(SGOT)/ALT(SPGT): ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present
- creatinine: < 1.5 X upper limit of normal
- The effects of TAS-102 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because topoisomerase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- 1. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to swallow tablets
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1.
- All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases due to poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102, irinotecan or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Prior treatment with irinotecan or TAS-102
- History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.
- Inability to comply with study and follow-up procedures as judged by the Investigator
- Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: A Phase Ib Multicenter Study of TAS-102 in Combination With Irinotecan in Patients With Advanced Recurrent or Unresectable Gastric and Gastroesophageal Adenocarcinoma After at Least One Line of Treatment With a Fluoropyrimidine and Platinum Containing Regimen
This is a phase Ib single-arm, open-label clinical trial determining the feasibility and efficacy of TAS-102 and irinotecan in subjects with advanced gastric and gastroesophageal adenocarcinoma. These are subjects who are not candidates for curative treatments and who have received at least one prior line of chemotherapy with a fluoropyrimidine and platinum agent.
Read the detailed description
Treatment on study will be administered in 14 day cycles.
- Conditions
- Gastric Adenocarcinoma, GastroEsophageal Cancer
- Being tested
- TAS-102, Irinotecan
- Keywords
- Gastric Adenocarcinoma, TAS-102, Irinotecan, Gastroesophageal Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102Drug
Also called LONSURF, trifluoridine and tipiracil
Given PO
IrinotecanDrug
Also called CAMPTOSAR, CPT-11
Given IV
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 and Irinotecan | Experimental | Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. Receives: Drug: TAS-102; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Progression-free Survival at 6 Months
This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined as death, radiographic progression or clinical deterioration attributed to disease progression as judged by an investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions and an absolute increase of an least 5 mm and/or appearance of new lesions.
Measured: 6 Months
Secondary outcomes (3)
Number of Participants With Grade 3-5 Adverse Events
To evaluate the tolerability of administering TAS-102 in combination with Irinotecan in patients with advanced recurrent or unresectable gastric and gastroesophageal adenocarcinoma for the first 2 cycles of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
Measured: 8 Weeks
Objective Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan
To assess the objective response rate to the combination of TAS-102 and Irinotecan. Objective response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR
Measured: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Overall Survival of Patients of Patients Who Received TAS-102 and Irinotecan
To evaluate overall survival in patients with advanced recurrent or unresectable and gastroesophageal adenocarcinoma treated with this combination of TAS-102 and Irinotecan.
Measured: From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start26 Aug 2019
- Primary completion14 Jul 2021
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Farshid Dayyani, University of California, Irvine
- Investigators
- Farshid Dayyani, MD, PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074343
- Sponsor's protocol ID
- UCI 18-125 [HS# 2019-5179]
- Other IDs
- 2019-5179
- Status last verified
- May 2023
- First submitted
- 28 Aug 2019
- Last updated
- 2 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Multicenter Study of TAS-102 in Combination With Irinotecan in Patients With Advanced Recurrent or Unresectable Gastric and Gastroesophageal Adenocarcinoma After at Least One Line of Treatment With a Fluoropyrimidine and Platinum Containing Regimen
- ClinicalTrials.gov ID
- NCT04074343
- Acronym / sponsor ID
- UCI 18-125 [HS# 2019-5179]
- Conditions
- Gastric Adenocarcinoma, GastroEsophageal Cancer
- Keywords
- Gastric Adenocarcinoma, TAS-102, Irinotecan, Gastroesophageal Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Posted 2 Feb 2024
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 phase Ib single-arm, open-label clinical trial determining the feasibility and efficacy of TAS-102 and irinotecan in subjects with advanced gastric and gastroesophageal adenocarcinoma. These are subjects who are not candidates for curative treatments and who have received at least one prior line of chemotherapy with a fluoropyrimidine and platinum agent.
Detailed description
Treatment on study will be administered in 14 day cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-102 and Irinotecan | Experimental | Drug: TAS-102, Drug: IrinotecanPatients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must have histologically or cytologically confirmed gastric or gastroesophageal adenocarcinoma
- Must have locally advanced, recurrent, or metastatic disease not amenable to curative intent surgery.
- Must have progressed, or not tolerated, at least one line of treatment with a platinum and/or fluoropyrimidine containing regimen. At least one cycle of combination chemotherapy including a platinum (oxaliplatin, cisplatin, carboplatin) and/or fluoropyrimidine (capecitabine or 5-Fluorouracil) based regimen for advanced disease. Combination regimens with platinum/fluoropyrimidine containing a taxane and or a checkpoint inhibitor are allowed. Patients progressing within six months of perioperative chemotherapy or definitive chemoradiation for localized disease are eligible. Patients who have exhausted all other standard of care options are also eligible.
- Age ≥ 18 years
- Performance status: ECOG performance status ≤2
Key exclusion criteria (10 listed)
- Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1.
- All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases due to poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102, irinotecan or other agents used in 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 |
|---|---|---|
| TAS-102Also: LONSURF, trifluoridine and tipiracilGiven PO | Drug | TAS-102 and Irinotecan |
| IrinotecanAlso: CAMPTOSAR, CPT-11Given IV | Drug | TAS-102 and Irinotecan |
Primary outcome
Percentage of Participants With Progression-free Survival at 6 Months
Time frame: 6 Months
This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined as death, radiographic progression or clinical deterioration attributed to disease progression as judged by an investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions and an absolute increase of an least 5 mm and/or appearance of new lesions.
3 secondary outcomes
Number of Participants With Grade 3-5 Adverse Events
Time frame: 8 Weeks
Objective Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan
Time frame: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Overall Survival of Patients of Patients Who Received TAS-102 and Irinotecan
Time frame: From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Farshid Dayyani, MD, PhD principal investigator
Chao Family Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAS-102 and Irinotecan in people with Gastric Adenocarcinoma and GastroEsophageal Cancer, run by University of California, Irvine at 2 sites in United States.
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 19 inclusion and 10 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 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Progression-free Survival at 6 Months (time frame: 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 2 Feb 2024.