Solid TumorsPhase 1NCT00921869
A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
A Phase 1 study testing E7050 in people with Solid Tumors, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- E7050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2009to Jun 2011
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a histological or cytological diagnosis of solid tumors or gastric cancer.
- Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
- Subjects with adequate organ function.
- Patients who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.
- Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
Who cannot join
- Subjects who have brain metastases with clinical symptoms or which requires treatment.
- Subjects with the serious complications or disease history.
- Subjects who cannot take oral medication.
- Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
- Female subjects who are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients with advanced solid tumors.
Read the detailed description
Phase I, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) of E7050 given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
- Conditions
- Solid Tumors
- Being tested
- E7050
- Keywords
- Cancer, Gastrointestinal Cancer
- Medical subject headings
- Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7050Drug
The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E7050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT)
Measured: During the Run-in Phase and the first 5 weeks of treatment
Secondary outcomes (5)
Dose-limiting toxicities.
Measured: During the Run-in Phase and the first 5 weeks of treatment
Incidence and severity of adverse events and their drug relationship.
Measured: Throughout the entire study
PK of blood and urine
Measured: During the Run-in Phase, Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; Day 28 of Cycle 1 for urine
Pharmacodynamic (PD) biomarker analysis of blood and tumor tissue samples.
Measured: During Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; on Day 22 of Cycle 1 for optional tumor biopsies
Best overall tumor response, duration of response and stable disease, assessed by Response Evaluation Criteria in Solid Tumors.
Measured: Every 4 weeks for complete and partial response; by 7th week for stable disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takashi Sawada, Study director, Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921869
- Sponsor's protocol ID
- E7050-J081-102
- Status last verified
- Dec 2017
- First submitted
- 15 Jun 2009
- Last updated
- 26 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT00921869
- Acronym / sponsor ID
- E7050-J081-102
- Conditions
- Solid Tumors
- Keywords
- Cancer, Gastrointestinal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Jun 2009 (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 study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients with advanced solid tumors.
Detailed description
Phase I, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) of E7050 given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E7050 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with a histological or cytological diagnosis of solid tumors or gastric cancer.
- Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
- Subjects with adequate organ function.
- Patients who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.
- Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
Key exclusion criteria (5 listed)
- Subjects who have brain metastases with clinical symptoms or which requires treatment.
- Subjects with the serious complications or disease history.
- Subjects who cannot take oral medication.
- Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
- Female subjects who are pregnant or breast-feeding.
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 |
|---|---|---|
| E7050The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy. | Drug | 1 |
Primary outcome
Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT)
Time frame: During the Run-in Phase and the first 5 weeks of treatment
5 secondary outcomes
Dose-limiting toxicities.
Time frame: During the Run-in Phase and the first 5 weeks of treatment
Incidence and severity of adverse events and their drug relationship.
Time frame: Throughout the entire study
PK of blood and urine
Time frame: During the Run-in Phase, Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; Day 28 of Cycle 1 for urine
Pharmacodynamic (PD) biomarker analysis of blood and tumor tissue samples.
Time frame: During Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; on Day 22 of Cycle 1 for optional tumor biopsies
Best overall tumor response, duration of response and stable disease, assessed by Response Evaluation Criteria in Solid Tumors.
Time frame: Every 4 weeks for complete and partial response; by 7th week for stable disease
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 26 Dec 2017.
Related trials for Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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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.
Takashi Sawada study director
Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E7050 in people with Solid Tumors, run by Eisai Co., Ltd. at 1 site in Japan.
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 5 inclusion and 5 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 26 Dec 2017. 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 Japan. 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?
Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT) (time frame: During the Run-in Phase and the first 5 weeks of treatment). 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 26 Dec 2017.