Condition or disease | Intervention/treatment | Phase |
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Neoplasms Carcinoma, Hepatocellular Liver Neoplasms | Drug: E7386 Drug: Lenvatinib | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Phase 1b Study of E7386 in Combination With Other Anticancer Drug in Subjects With Solid Tumor |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | March 31, 2022 |
Estimated Study Completion Date : | March 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Hepatocellular Carcinoma (HCC) Part
Participants with HCC will receive E7386 tablets, alone orally, once daily (QD) for 5 or 6 consecutive days followed by 48 hours of without treatment in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386 tablets, orally, QD in combination with lenvatinib capsules, orally, QD in 28-day treatment cycles until disease progression (PD), development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.
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Drug: E7386
E7386, tablets, orally.
Drug: Lenvatinib Lenvatinib, capsules, orally.
Other Name: Lenvima
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Experimental: Other Solid Tumor (ST) Part
Participants with ST (except for HCC) will receive E7386 tablets, alone orally, QD for 5 or 6 consecutive days followed by 48 hours of without treatment in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386 tablets, orally, QD in combination with lenvatinib capsules, orally in 28-day treatment cycles until PD, development of unacceptable toxicity, participant's request to discontinue, withdrawal of consent, or termination of the study program. Dose escalation of E7386 and lenvatinib will be based on the available safety data from the previous cohorts.
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Drug: E7386
E7386, tablets, orally.
Drug: Lenvatinib Lenvatinib, capsules, orally.
Other Name: Lenvima
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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
HCC part only:
Participants with confirmed diagnosis of unresectable HCC with any of the following criteria:
ST part only (except for HCC ):
Participants with histologically or cytologically confirmed diagnosis of solid tumor for which no alternative standard therapy or no effective therapy exists
Exclusion Criteria:
Any of cardiac conditions as follows:
Contact: Inquiry Service | eisai-chiken_hotline@hhc.eisai.co.jp |
Japan | |
Eisai Trial Site #2 | Recruiting |
Kashiwa, Chiba, Japan | |
Eisai Trial Site #3 | Recruiting |
Osakasayama, Osaka, Japan | |
Eisai Trial Site #1 | Recruiting |
Chuo-Ku, Tokyo, Japan |
Tracking Information | |||||
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First Submitted Date ICMJE | June 24, 2019 | ||||
First Posted Date ICMJE | July 5, 2019 | ||||
Last Update Posted Date | August 31, 2020 | ||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||
Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor | ||||
Official Title ICMJE | An Open-label Phase 1b Study of E7386 in Combination With Other Anticancer Drug in Subjects With Solid Tumor | ||||
Brief Summary | The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
42 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 31, 2022 | ||||
Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04008797 | ||||
Other Study ID Numbers ICMJE | E7386-J081-102 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Eisai Inc. | ||||
Study Sponsor ICMJE | Eisai Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Eisai Inc. | ||||
Verification Date | March 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |