NeoplasmsPhase 1NCT02025803
A Safety, Tolerability and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors
A Phase 1 study testing TAS-114/capecitabine in people with Neoplasms, run by Taiho Oncology, Inc. at 3 sites in United States.
Trial summary
The purpose of this exploratory study is to investigate the safety and determine the maximum tolerated dose (MTD) of TAS-114 in combination with capecitabine in patients with advanced solid tumors for which the patients have no available therapy likely to convey clinical benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- TAS-114/capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2012to 7 Jul 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided written consent
- Is 18 years of age or older
- Has histologically or cytologically confirmed advanced, measurable or non-measurable metastatic solid tumors for which the patients have no available therapy to convey clinical benefit Expansion Phase only: The target population should include at least
- 12 patients with breast cancer for whom 5 FU chemotherapy is the standard treatment
- 28 patients with refractory colorectal cancer.
- May have received prior therapies for advanced or metastatic disease
Show all 12Show fewer
- Expansion Phase only: Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009), ie, has at least one measurable lesion
- Has ECOG performance status 0 or 1 on Cycle 1, Day 1
- Is able to take medications orally
- Has adequate organ function as defined by protocol
- Women of childl-bearing potential must have a negative pregnancy test within 7 days prior to starting the study drug. Beth males and females must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose
- Is willing to and able to comply with scheduled visits and study procedures.
Who cannot join
- Has a known DPD deficiency
- Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration.
- Certain serious illnesses or medical conditions
- Is receiving concomitant treatment with drugs that may interact with capecitabine
- Has had prior gastrectomy
- Has known sensitivity to capecitabine or metabolites
- Is a pregnant or lactating female
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
IU Simon Cancer Center
Indianapolis, Indiana, 46202
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Phase 1, Open-Label, Non-randomized, Dose-Escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors
The purpose of this exploratory study is to investigate the safety and determine the maximum tolerated dose (MTD) of TAS-114 in combination with capecitabine in patients with advanced solid tumors for which the patients have no available therapy likely to convey clinical benefit.
Read the detailed description
In animal models, co-administration of TAS 114 and capecitabine has shown antitumor effects exceeding the maximum efficacy obtained by capecitabine alone. Developing a novel chemotherapy based on the combined use of TAS-114 and capecitabine may fulfill the need for more efficacious treatment for patients with advanced solid tumors.
The study, evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of the TAS-114/ capecitabine regimen in patients with advanced solid tumors, will be conducted in two parts: a Dose-Escalation Phase (Part 1) to determine the MTD; and an Expansion Phase (Part 2) to further evaluate the safety and preliminary efficacy with the MTD.
- Conditions
- Neoplasms
- Being tested
- TAS-114/capecitabine
- Keywords
- Advanced solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-114/capecitabineDrug
Part 1 (dose-escalation phase):
Treatment cycles of TAS-114 and capecitabine orally BID for 14 days followed by 7 days rest until at least one of the discontinuation criteria are met TAS-114 dose starting at 20mg/m2/day with capecitabine dose of 760 mg/m2/day. TAS-114 doses will be escalated for each cohort up to 480mg/m2/day. If MTD is not reached by TAS-114 dose of 480mg/m2/day, the capecitabine dose will be escalated
Part 2 (expansion phase):
TAS-114 and capecitabine MTD established in Part 1 administered BID for 14 days followed by 7-day recovery period (21-day cycle).
| Study group | Role | What they receive |
|---|---|---|
| TAS-114/capecitabine | Experimental | See intervention description Receives: Drug: TAS-114/capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MTD of TAS-114/ capecitabine (defined as the highest dose level at which less than 33% of the patients experience a Dose Limiting Toxicity (DLT) during the first cycle of treatment); DLTs defined by protocol
Only drug-related toxicities during the first cycle are considered in the assessment of DLTs.
Measured: First cycle of treatment (ie. 21 days)
Secondary outcomes (2)
Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, capecitabine and it's metabolite 5-FU)
Measured: First cycle of treatment (ie. 21 days)
antitumor activity by tumor assessments according to RECIST criteria
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startNov 2012
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025803
- Sponsor's protocol ID
- TPU-TAS-114-101
- Status last verified
- Aug 2024
- First submitted
- 27 Dec 2013
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Non-randomized, Dose-Escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02025803
- Acronym / sponsor ID
- TPU-TAS-114-101
- Conditions
- Neoplasms
- Keywords
- Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Nov 2012
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 1 Jan 2014 (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 purpose of this exploratory study is to investigate the safety and determine the maximum tolerated dose (MTD) of TAS-114 in combination with capecitabine in patients with advanced solid tumors for which the patients have no available therapy likely to convey clinical benefit.
Detailed description
In animal models, co-administration of TAS 114 and capecitabine has shown antitumor effects exceeding the maximum efficacy obtained by capecitabine alone. Developing a novel chemotherapy based on the combined use of TAS-114 and capecitabine may fulfill the need for more efficacious treatment for patients with advanced solid tumors.
The study, evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of the TAS-114/ capecitabine regimen in patients with advanced solid tumors, will be conducted in two parts: a Dose-Escalation Phase (Part 1) to determine the MTD; and an Expansion Phase (Part 2) to further evaluate the safety and preliminary efficacy with the MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-114/capecitabine | Experimental | Drug: TAS-114/capecitabineSee intervention description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provided written consent
- Is 18 years of age or older
- Has histologically or cytologically confirmed advanced, measurable or non-measurable metastatic solid tumors for which the patients have no available therapy to convey clinical benefit Expansion Phase only: The target population should include at least
- May have received prior therapies for advanced or metastatic disease
- Expansion Phase only: Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Version 1.1, 2009), ie, has at least one measurable lesion
Key exclusion criteria (7 listed)
- Has a known DPD deficiency
- Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration.
- Certain serious illnesses or medical conditions
- Is receiving concomitant treatment with drugs that may interact with capecitabine
- Has had prior gastrectomy
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-114/capecitabinePart 1 (dose-escalation phase): Treatment cycles of TAS-114 and capecitabine orally BID for 14 days followed by 7 days rest until at least one of the discontinuation criteria are met TAS-114 dose starting at 20mg/m2/day with capecitabine dose of 760 mg/m2/day. TAS-114 doses will be escalated for each cohort up to 480mg/m2/day. If MTD is not reached by TAS-114 dose of 480mg/m2/day, the capecitabine dose will be escalated Part 2 (expansion phase): TAS-114 and capecitabine MTD established in Part 1 administered BID for 14 days followed by 7-day recovery period (21-day cycle). | Drug | TAS-114/capecitabine |
Primary outcome
The MTD of TAS-114/ capecitabine (defined as the highest dose level at which less than 33% of the patients experience a Dose Limiting Toxicity (DLT) during the first cycle of treatment); DLTs defined by protocol
Time frame: First cycle of treatment (ie. 21 days)
Only drug-related toxicities during the first cycle are considered in the assessment of DLTs.
2 secondary outcomes
Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, capecitabine and it's metabolite 5-FU)
Time frame: First cycle of treatment (ie. 21 days)
antitumor activity by tumor assessments according to RECIST criteria
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
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 5 Sep 2024.
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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.
3 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-114/capecitabine in people with Neoplasms, run by Taiho Oncology, Inc. at 3 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 12 inclusion and 7 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 MTD of TAS-114/ capecitabine (defined as the highest dose level at which less than 33% of the patients experience a Dose Limiting Toxicity (DLT) during the first cycle of treatment); DLTs defined by protocol (time frame: First cycle of treatment (ie. 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 5 Sep 2024.