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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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The primary purpose of the study is to evaluate safety and tolerability of E7389 liposomal formulation (E7389-LF) in combination with nivolumab and to determine the recommended Phase 2 dose (RP2D) in Phase 1b part and to evaluate objective response rate (ORR) of E7389-LF and nivolumab using RP2D in each tumor type in Phase 2 part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b, Cohort 1: E7389-LF Dose 1 + Nivolumab Dose 1 | Experimental | Participants will receive E7389-LF (intravenous) Dose 1 and nivolumab (intravenous) Dose 1 on specified days. |
|
| Phase 1b, Cohort 2: E7389-LF Dose 2 + Nivolumab Dose 1 | Experimental | Participants will receive E7389-LF (intravenous) Dose 2 and nivolumab (intravenous) Dose 1 on specified days. |
|
| Phase 1b, Cohort 3: E7389-LF Dose 3 + Nivolumab Dose 2 | Experimental | Participants will receive E7389-LF (intravenous) Dose 3 and nivolumab (intravenous) Dose 2 on specified days. |
|
| Phase 1b, Cohort 4: E7389-LF Dose 4 + Nivolumab Dose 2 | Experimental | Participants will receive E7389-LF (intravenous) Dose 4 and nivolumab (intravenous) Dose 2 on specified days. |
|
| Phase 2, Cohort-1: E7389-LF + Nivolumab | Experimental | Participants with gastric cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7389-LF | Drug | E7389-LF Intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs) | DLTs are defined as study drug related adverse events (AEs). Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0). | Baseline up to Cycle 1 (Cycle length is equal to [=] up to 28 days) |
| Phase 2: ORR | ORR is defined as the percentage of participants who have best overall response of complete response (CR) or partial response (PR). The ORR will be assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version 1.1. | Baseline up to End of Treatment (Up to approximately 79 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b and Phase 2: Number of Participants With AEs and Serious Adverse Events (SAEs) | Up to 30 days after the last dose of study drug or before initiating post anti-cancer treatment, whichever shorter (up to approximately 79 months) | |
| Phase 1b and Phase 2: Number of Participants With Markedly Abnormal Laboratory Evaluations |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site #13 | Nagoya | Aichi-ken | Japan | |||
| Eisai Trial Site #18 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39516370 | Derived | Oshima T, Yamamoto S, Kawakami H, Makino T, Kawazoe A, Masuishi T, Tsushima T, Hirao M, Tsuda M, Hino K, Yamamoto N, Hara H, Kaname S, Matsuoka D, Otake Y, Yasuda K, Takase T, Takashima S, Semba T, Ooki A. Phase 1b/2 study of the liposomal formulation of eribulin (E7389-LF) in combination with nivolumab: Results from the phase 2 esophageal cancer cohort. BJC Rep. 2024 Sep 4;2(1):66. doi: 10.1038/s44276-024-00066-6. | |
| 38295160 |
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Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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|
| Phase 2, Cohort-2: E7389-LF + Nivolumab | Experimental | Participants with esophageal cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part. |
|
| Phase 2, Cohort-3: E7389-LF + Nivolumab | Experimental | Participants with small lung cancer will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part. |
|
| Nivolumab | Drug | Nivolumab Intravenous infusion. |
|
|
| Baseline up to End of Treatment (Up to approximately 79 months) |
| Phase 1b and Phase 2: Number of Participants With Markedly Abnormal Vital Signs | Baseline up to End of Treatment (Up to approximately 79 months) |
| Phase 1b and Phase 2: Number of Participants With Clinically Abnormal 12-lead Electrocardiogram (ECG) | Baseline up to End of Treatment (Up to approximately 79 months) |
| Phase 1b and Phase 2: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Baseline up to End of Treatment (Up to approximately 79 months) |
| Phase 1b and 2: Number of Participants With Clinically Significant Abnormal Physical Examination Findings | Baseline up to End of Treatment (Up to approximately 79 months) |
| Phase 1b and Phase 2, Cmax: Maximum Observed Plasma Concentration of E7389-LF | Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days) |
| Phase 1b and Phase 2: Serum Concentration of Nivolumab | Up to Cycle 13 (each Cycle length = up to 28 days) |
| Phase 1b and Phase 2, Tmax: Time to Maximum Observed Plasma Concentration (Cmax) of E7389-LF | Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days) |
| Phase 1b and Phase 2, AUC: Area Under the Plasma Concentration-time Curve Over Time From 0 to Last Measurable Concentration of E7389-LF | Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days) |
| Phase 1b and Phase 2, T1/2: Terminal Phase Elimination Half-life of E7389-LF | Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days) |
| Phase 1b and Phase 2, CL: Total Body Clearance of E7389-LF | Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days) |
| Phase 1b and Phase 2, Vd: Volume of Distribution of E7389-LF | Phase 1b, Cycle 1 Day 1: 0 to 24 hours, Cycle 1 Days 4 and 8; Phase 2, Cycle 1 Days 1 and 8 (Cycle length = up to 28 days) |
| Phase 2: Progression-Free Survival (PFS) | PFS is defined as the time from the date of the first administration of drug to the date of the first documentation of disease progression or death due to any cause, whichever comes first. The PFS will be assessed by investigator based on RECIST version 1.1. | From the first does of the study drug up to the first documentation of disease progression or death due to any cause, whichever comes first (up to approximately 79 months) |
| Kashiwa |
| Chiba |
| Japan |
| Eisai Trial Site #2 | Kashiwa | Chiba | Japan |
| Eisai Trial Site #14 | Matsuya | Ehime | Japan |
| Eisai Trial Site #4 | Kurume | Fukuoka | Japan |
| Eisai Trial Site #11 | Akashi | Hyōgo | Japan |
| Eisai Trial Site #15 | Yokohama | Kanaga | Japan |
| Eisai Trial Site #3 | Sendai | Miyagi | Japan |
| Eisai Trial Site #6 | Chuo Ku | Osaka | Japan |
| Eisai Trial Site #8 | Chuo Ku | Osaka | Japan |
| Eisai Trial Site #5 | Osakasa | Osaka | Japan |
| Eisai Trial Site #7 | Sakai C | Osaka | Japan |
| Eisai Trial Site #17 | Suita | Osaka | Japan |
| Eisai Trial Site #19 | Kitaadachi-gun | Saitama | Japan |
| Eisai Trail Site #16 | Sunto-g | Shizuo | Japan |
| Eisai Trial Site #1 | Chuo Ku | Tokyo | Japan |
| Eisai Trial Site #10 | Koto-Ku | Tokyo | Japan |
| Eisai Trial Site #9 | Wakayama | Wakaya | Japan |
| Eisai Trial Site #12 | Kōtoku | Japan |
| Derived |
| Kawazoe A, Yamamoto N, Sugimoto N, Kawakami H, Oshima T, Yamaguchi K, Hino K, Hirao M, Kurokawa Y, Kawakami T, Tsuda M, Hara H, Kaname S, Matsuoka D, Otake Y, Yasuda K, Takase T, Takashima S, Semba T, Muro K. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Gastric Cancer Cohort. Clin Cancer Res. 2024 Apr 1;30(7):1264-1272. doi: 10.1158/1078-0432.CCR-23-1768. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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