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Phase 1 Study of E7090 in Subjects With Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02275910
Recruitment Status : Active, not recruiting
First Posted : October 27, 2014
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE October 20, 2014
First Posted Date  ICMJE October 27, 2014
Last Update Posted Date September 5, 2021
Actual Study Start Date  ICMJE October 28, 2014
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
Safety and tolerability of E7090 as a measure of Adverse Events/ Serious Adverse Events [ Time Frame: Upto 30 days after last administration of drug ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • Best Overall Response (BOR) in targeted population [ Time Frame: From screening until the date of discontinuation, assessed up to 100 months. ]
    Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) will be performed based on RECIST v1.1 (Response Evaluation Criteria In Solid Tumors). Tumor marker will also be measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) will also be evaluated. Best overall response are complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE), where SD have to be achieved at >= 7 weeks after first dose.
  • Objective Response Rate (ORR) [ Time Frame: From screening until the date of discontinuation, assessed up to 100 months. ]
    ORR is defined as a proportion of subjects with BOR of CR or PR.
  • Disease Control Rate (DCR) [ Time Frame: From screening until the date of discontinuation, assessed up to 100 months. ]
    DCR is defined as the proportion of subjects who with BOR of CR, PR or SD.
  • Progression- Free Survival (PFS) [ Time Frame: From the date of first dose until the first documented date of event (disease progression or death from any cause), assessed up to 100 months. ]
    PFS is defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first).
  • Overall Survival (OS) [ Time Frame: From the date of first dose until the date of death from any cause, assessed up to 100 months. ]
    OS is defined as the time from the date of first dose to the date of death from any cause.
  • Maximum tolerated Dose (MTD) of E7090 (part 1) and Recommended Dose (RD) for future studies [ Time Frame: On day 35 ]
  • Plasma Cmax (maximum concentration) of E7090 [ Time Frame: On day 36 ]
  • Plasma tmax (Time of maximum concentration) of E7090 [ Time Frame: On day 36 ]
  • Plasma AUC (Area under the concentration vs time curve) of E7090 [ Time Frame: On day 36 ]
  • Pharmacokinetics (PK) of Urine (renal clearance) [ Time Frame: On day 36 ]
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 Phase 1 Study of E7090 in Subjects With Solid Tumor
Official Title  ICMJE A Phase 1 Study of E7090 in Subjects With Solid Tumor
Brief Summary

This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts:

  1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and
  2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tumors
Intervention  ICMJE Drug: E7090
Study Arms  ICMJE Experimental: E7090 Arm
Oral, starting dose 1 mg once a day, dose escalation in part 1. Cycle 0 is for 7 days. For Cycle 1 and onward, each cycle is 28 days long. The Cycle 0 is set up for PK analysis of a single dose of E7090. In the following Cycle 1, subjects will be administered E7090 QD, and the PK and safety will be assessed for 28 days. One or two doses may be selected from part 1 for Part 2. E7090 will be administered continuously once a daily. Subjects can continue treatment unless they meet discontinuation criteria.
Intervention: Drug: E7090
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Part 1and Part 2

  1. Provide written informed consent
  2. Male or female subjects age >= 20 years at the time of informed consent
  3. Subjects with a histological and/or cytological diagnosis of solid tumor
  4. Subjects who failed standard therapies, or for which no appropriate treatment is available.
  5. Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)
  6. Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.

    Inclusion Criteria: Part 2 only

  7. Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.

Exclusion criteria

  1. Patients with brain metastasis who have clinical symptoms or requiring treatment.
  2. Medical history of clinically significant cardiovascular impairment
  3. Concomitant systemic infection requiring medical treatment
  4. Effusion requiring drainage
  5. Known intolerance to the study drug (or any of excipients)
  6. Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).
  7. Inability to take oral medication, or malabsorption syndrome, or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7090.
  8. Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator
  9. Females who are pregnant or breastfeeding
  10. Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02275910
Other Study ID Numbers  ICMJE E7090-J081-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( Eisai Co., Ltd. )
Study Sponsor  ICMJE Eisai Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP