Clinical Trials /

Phase 1 Study of E7090 in Subjects With Solid Tumor

NCT02275910

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase 1 Study of E7090 in Subjects With Solid Tumor
  • Official Title: A Phase 1 Study of E7090 in Subjects With Solid Tumor

Clinical Trial IDs

  • ORG STUDY ID: E7090-J081-101
  • NCT ID: NCT02275910

Conditions

  • Tumors

Interventions

DrugSynonymsArms
E7090E7090 Arm

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
E7090 ArmExperimentalOral, 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.
  • E7090

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of E7090 as a measure of Adverse Events/ Serious Adverse Events
Time Frame:Upto 30 days after last administration of drug
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Best Overall Response (BOR) in targeted population
Time Frame:From screening until the date of discontinuation, assessed up to 100 months.
Safety Issue:
Description: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.
Measure:Objective Response Rate (ORR)
Time Frame:From screening until the date of discontinuation, assessed up to 100 months.
Safety Issue:
Description:ORR is defined as a proportion of subjects with BOR of CR or PR.
Measure:Disease Control Rate (DCR)
Time Frame:From screening until the date of discontinuation, assessed up to 100 months.
Safety Issue:
Description:DCR is defined as the proportion of subjects who with BOR of CR, PR or SD.
Measure: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.
Safety Issue:
Description: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).
Measure:Overall Survival (OS)
Time Frame:From the date of first dose until the date of death from any cause, assessed up to 100 months.
Safety Issue:
Description:OS is defined as the time from the date of first dose to the date of death from any cause.
Measure:Maximum tolerated Dose (MTD) of E7090 (part 1) and Recommended Dose (RD) for future studies
Time Frame:On day 35
Safety Issue:
Description:
Measure:Plasma Cmax (maximum concentration) of E7090
Time Frame:On day 36
Safety Issue:
Description:
Measure:Plasma tmax (Time of maximum concentration) of E7090
Time Frame:On day 36
Safety Issue:
Description:
Measure:Plasma AUC (Area under the concentration vs time curve) of E7090
Time Frame:On day 36
Safety Issue:
Description:
Measure:Pharmacokinetics (PK) of Urine (renal clearance)
Time Frame:On day 36
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eisai Co., Ltd.

Trial Keywords

  • Solid Tumors
  • E7090

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