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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Active combination of E7070 and irinotecan. |
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| 2 | Other | Active combination of E7070 and irinotecan. |
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| 3 | Other | Active combination of E7070 and irinotecan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7070 + irinotecan combination | Drug | Escalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination. |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the Maximum tolerated dose of E7070 in combination with irinotecan in patients with GI tract, pancreatic or lung tumors. | 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, E7070 activity and Pharmacokinetics | 1st arm: D1, D8, Q3WK; 2nd arm: D1, D8, Q3WK; 3rd arm: D1, D15, Q4WK |
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Inclusion Criteria:
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:
Patients must meet the following screening values for liver function:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eisai Medical Services | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C439829 | N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Irinotecan + E7070 combination | Drug | Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination. |
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| Irinotecan + E7070 combination | Drug | Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination. |
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