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A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor

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ClinicalTrials.gov Identifier: NCT04078295
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
The primary purpose of the study is to evaluate safety and tolerability and to determine recommended Phase 2 dose (RP2D) of E7389-LF in combination with nivolumab in Phase 1b part, and to evaluate objective response rate (ORR) of E7389-LF and nivolumab using RP2D in Phase 2 part in each tumor type.

Condition or disease Intervention/treatment Phase
Solid Neoplasms Drug: E7389-LF Drug: Nivolumab Phase 1 Phase 2

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Study Type : Interventional
Estimated Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1b/2 Study of E7389 Liposomal Formulation Plus Nivolumab in Subjects With Solid Tumor
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1b: E7389-LF + Nivolumab
Participants will receive specified doses of E7389-LF (intravenous) and nivolumab (intravenous) on specified days.
Drug: E7389-LF
E7389-LF Intravenous infusion.

Drug: Nivolumab
Nivolumab Intravenous infusion.
Other Name: ONO-4538

Experimental: Phase 2, Cohort-1: E7389-LF + Nivolumab
Participants will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
Drug: E7389-LF
E7389-LF Intravenous infusion.

Drug: Nivolumab
Nivolumab Intravenous infusion.
Other Name: ONO-4538

Experimental: Phase 2, Cohort-2: E7389-LF + Nivolumab
Participants will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
Drug: E7389-LF
E7389-LF Intravenous infusion.

Drug: Nivolumab
Nivolumab Intravenous infusion.
Other Name: ONO-4538

Experimental: Phase 2, Cohort-3: E7389-LF + Nivolumab
Participants will receive RP2D of E7389-LF (intravenous) and nivolumab (intravenous) determined in Phase 1b part.
Drug: E7389-LF
E7389-LF Intravenous infusion.

Drug: Nivolumab
Nivolumab Intravenous infusion.
Other Name: ONO-4538




Primary Outcome Measures :
  1. Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline up to Cycle 1 (Cycle length is equal to [=] up to 28 days) ]
    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).

  2. Phase 1b: RP2D of E7389-LF in Combination With Nivolumab [ Time Frame: Up to 12 Months ]
  3. Phase 2: ORR [ Time Frame: Up to 36 Months ]
    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.


Secondary Outcome Measures :
  1. Phase 1b and Phase 2: Number of Participants With AEs and Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after the last dose of study drug or before initiating post anti-cancer treatment, whichever shorter (up to 36 Months) ]
  2. Phase 1b and Phase 2, Cmax: Maximum Observed Plasma Concentration of E7389-LF [ Time Frame: 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) ]
  3. Phase 1b and Phase 2: Serum Concentration of Nivolumab [ Time Frame: Up to 36 Months ]
  4. Phase 1b and Phase 2, Tmax: Time to Maximum Observed Plasma Concentration (Cmax) of E7389-LF [ Time Frame: 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) ]
  5. Phase 1b and Phase 2, AUC: Area Under the Plasma Concentration-time Curve Over Time From 0 to Last Measurable Concentration of E7389-LF [ Time Frame: 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) ]
  6. Phase 1b and Phase 2, T1/2: Terminal Phase Elimination Half-life of E7389-LF [ Time Frame: 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) ]
  7. Phase 1b and Phase 2, CL: Total Body Clearance of E7389-LF [ Time Frame: 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) ]
  8. Phase 1b and Phase 2, Vd: Volume of Distribution of E7389-LF [ Time Frame: 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) ]
  9. Phase 2: Progression-Free Survival (PFS) [ Time Frame: 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 36 Months) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Phase 1b part only: Participants with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists (participants who will be the candidate of treatment by nivolumab monotherapy as standard therapy is acceptable)
  2. Phase 2 part only: Nonresectable specific solid tumor participants with confirmed diagnosis who showed disease progression by investigator's assessment during or after 1st line chemotherapy and did not receive any other systemic chemotherapy to advanced/recurrent disease
  3. Participants who have accessible tumors for biopsy and agree with tumor biopsy for pre and post treatment of study drug (If a pre-treatment biopsy cannot be obtained due to safety issue, then an archival tumor tissue sample may be submitted)
  4. Life expectancy of greater than or equal to (>=) 12 weeks
  5. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) 0-1
  6. Phase 2 part only: At least one measurable lesion based on RECIST 1.1 (Lesions that have had radiotherapy or loco-regional therapies must show evidence of progressive disease to be deemed a measurable lesion)

Exclusion Criteria:

  1. Diagnosed with meningeal carcinomatosis
  2. Participants with brain or subdural metastases or invasion are not eligible
  3. Participants with any active, known, or suspected autoimmune disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078295


Contacts
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Contact: Inquiry Service eisai-chiken_hotline@hhc.eisai.co.jp

Locations
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Japan
Eisai Trial Site #2 Recruiting
Kashiwa, Chiba, Japan
Eisai Trial Site #1 Recruiting
Chuo Ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Ono Pharmaceutical Co. Ltd
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT04078295    
Other Study ID Numbers: E7389-J081-120
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
E7389 liposomal formulation
Nivolumab
Neoplasms
Solid Tumor
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents