CancerPhase 1NCT00060567
Dose-Finding Study of E7070 in Combination With Irinotecan
A Phase 1 study testing E7070 + irinotecan combination and Irinotecan + E7070 combination in people with Cancer, run by Eisai Inc. at 1 site in United States.
Trial summary
E7070 and irinotecan will be administered to patients with GI tract, pancreatic or lung tumors on Days 1 and 8 of a 21-day cycle, or Days 1 and 15 of a 28-day cycle according to one of two E7070 dose escalation schemes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- E7070 + irinotecan combination and Irinotecan + E7070 combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Mar 2013
- 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
- Patients must have a histologically or cytologically confirmed refractory small cell lung carcinoma or relapsed pancreatic cancer.
- Patients should not have received more than two previous regimens of chemotherapy (prior epidermal growth factor directed therapy antiangiogenic therapy, or capecitabine do not constitute a previous regimen),
- Patients must be aged greater than or equal to 18 years,
- Patients must be ambulatory and have a Karnofsky performance status greater than or equal to 70%,
- Patients must have a life expectancy of greater than or equal to 3 months,
- Patients must meet the following screening hematologic values:
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- Hemoglobin greater than or equal to 10g /dL
- Absolute Neutrophil Count greater than or equal to 1.5 x 10^9/L
- Platelets greater than or equal to 100 x 109/L,
- Patients must meet the following screening values for liver function:
- Serum bilirubin less than or equal to 1.5 x upper limits of normal (ULN)
- ALAT and ASAT less than or equal to 2.5 x ULN (unless related to liver metastases, in which case less than or equal to 5 x ULN),
- Patients must have serum creatinine less than or equal to 1.5 x ULN,
- Patients must be willing and able to comply with the study protocol for the duration of the study, and
- Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
Who cannot join
- Patients who have received chemotherapy or radiation therapy (except palliative) or who have had major surgery within four weeks of treatment start,
- Patients who have received chemotherapy without recovering from chemotherapy related toxicity (defined as grade 1 or less) at study entry,
- Patients who have received palliative radiation therapy without recovering from radiation associated toxicity at study entry,
- Patients with a history of hypersensitivity to irinotecan,
- Patients who experienced greater than or equal to Grade 3 toxicity during previous therapy with irinotecan,
- Women who are pregnant or breastfeeding. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential),
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- Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception,
- Any history of uncontrolled seizures; CNS disorders; or psychological, familial, sociological or geographical conditions, judged by the Investigator to be clinically significant, and/or potentially capable of precluding informed consent or adversely affecting compliance with the study protocol and follow-up schedule,
- Patients must not have untreated brain metastases (Patients who have been treated for CNS metastases must be asymptomatic and radiologically stable for 4 weeks prior to entry),
- Patients with a history of conjugated hyperbilirubinemia,
- Patients with clinically significant cardiac or cardiovascular impairment,
- Patients with severe uncontrolled intercurrent infections,
- Patients with organ allografts,
- Patients who are receiving investigational drug treatment, immunotherapy, or biologic therapy. Treatment must have been completed four weeks prior to entry into the study and patients must have recovered from any associated toxicity.
- Patients with a history of hypersensitivity to sulfonamides,
- Patients with surgically resectable metastatic disease,
- Patients who are known to be positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), Hepatitis C antibody, or human immunodeficiency virus,
- Patients with significant disease, in the Investigator's opinion, that would exclude the patient from the study,
- Patients who are legally incapacitated,
- Patients who have a repeated demonstration of QTc greater than 470 ms (Bazett's correction),
- Patients with tumor, including metastasis, that is surgically resectable,
- Patients with clinical symptoms from brain metastasis,
- Patients taking steroids for the treatment of brain metastases, or
- Patients with leptomeningeal metastasis,
- Patients who have a history of additional risk factors for torsades de pointes (e.g., heart failure) or family history of Long QT Syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Dose-Finding Study of E7070 in Combination With Irinotecan
E7070 and irinotecan will be administered to patients with GI tract, pancreatic or lung tumors on Days 1 and 8 of a 21-day cycle, or Days 1 and 15 of a 28-day cycle according to one of two E7070 dose escalation schemes.
- Conditions
- Cancer
- Being tested
- E7070 + irinotecan combination, Irinotecan + E7070 combination
- Keywords
- E7070, Irinotecan, hydrochloride, gastrointestinal, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7070 + irinotecan combinationDrug
Escalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination.
Irinotecan + E7070 combinationDrug
Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
Irinotecan + E7070 combinationDrug
Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Active combination of E7070 and irinotecan. Receives: Drug: E7070 + irinotecan combination |
| 2 | Other | Active combination of E7070 and irinotecan. Receives: Drug: Irinotecan + E7070 combination |
| 3 | Other | Active combination of E7070 and irinotecan. Receives: Drug: Irinotecan + E7070 combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Maximum tolerated dose of E7070 in combination with irinotecan in patients with GI tract, pancreatic or lung tumors.
Measured: 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK
Secondary outcomes (1)
Safety, E7070 activity and Pharmacokinetics
Measured: 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2003 (estimated)
- Study startMar 2003
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Eisai 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eisai Medical Services, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060567
- Sponsor's protocol ID
- E7070-A001-106
- Status last verified
- Jun 2013
- First submitted
- 7 May 2003
- Last updated
- 18 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-Finding Study of E7070 in Combination With Irinotecan
- ClinicalTrials.gov ID
- NCT00060567
- Acronym / sponsor ID
- E7070-A001-106
- Conditions
- Cancer
- Keywords
- E7070, Irinotecan, hydrochloride, gastrointestinal, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 May 2003 (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.
E7070 and irinotecan will be administered to patients with GI tract, pancreatic or lung tumors on Days 1 and 8 of a 21-day cycle, or Days 1 and 15 of a 28-day cycle according to one of two E7070 dose escalation schemes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: E7070 + irinotecan combinationActive combination of E7070 and irinotecan. |
| 2 | Other | Drug: Irinotecan + E7070 combinationActive combination of E7070 and irinotecan. |
| 3 | Other | Drug: Irinotecan + E7070 combinationActive combination of E7070 and irinotecan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have a histologically or cytologically confirmed refractory small cell lung carcinoma or relapsed pancreatic cancer.
- Patients should not have received more than two previous regimens of chemotherapy (prior epidermal growth factor directed therapy antiangiogenic therapy, or capecitabine do not constitute a previous regimen),
- Patients must be aged greater than or equal to 18 years,
- Patients must be ambulatory and have a Karnofsky performance status greater than or equal to 70%,
- Patients must have a life expectancy of greater than or equal to 3 months,
Key exclusion criteria (25 listed)
- Patients who have received chemotherapy or radiation therapy (except palliative) or who have had major surgery within four weeks of treatment start,
- Patients who have received chemotherapy without recovering from chemotherapy related toxicity (defined as grade 1 or less) at study entry,
- Patients who have received palliative radiation therapy without recovering from radiation associated toxicity at study entry,
- Patients with a history of hypersensitivity to irinotecan,
- Patients who experienced greater than or equal to Grade 3 toxicity during previous therapy with irinotecan,
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 |
|---|---|---|
| E7070 + irinotecan combinationEscalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination. | Drug | 1 |
| Irinotecan + E7070 combinationEscalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination. | Drug | 2 |
| Irinotecan + E7070 combinationEscalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination. | Drug | 3 |
Primary outcome
To determine the Maximum tolerated dose of E7070 in combination with irinotecan in patients with GI tract, pancreatic or lung tumors.
Time frame: 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK
1 secondary outcome
Safety, E7070 activity and Pharmacokinetics
Time frame: 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK
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 18 Jun 2023.
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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.
Eisai Medical Services study director
Eisai Inc.
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 E7070 + irinotecan combination and Irinotecan + E7070 combination in people with Cancer, run by Eisai Inc. at 1 site 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 15 inclusion and 25 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 18 Jun 2023. 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 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?
To determine the Maximum tolerated dose of E7070 in combination with irinotecan in patients with GI tract, pancreatic or lung tumors. (time frame: 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK). 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 18 Jun 2023; AzTrials last refreshed its copy on 4 Nov 2026.