A Phase 2 Study of E7080 in Subjects With Advanced Thyroid Cancer
Overview
- Phase
- Phase 2
- Intervention
- E7080 capsule
- Conditions
- Thyroid Cancer
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 51
- Primary Endpoint
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
E7080
Intervention: E7080 capsule
Outcomes
Primary Outcomes
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years
Only TEAEs are included in the summary. For detailed list of adverse events (AEs), see the AE section. For each participant, only one TEAE in the same category was counted and for multiple TEAEs with different Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) grades, only the event with the highest grade was reported. All AEs were graded using CTCAE v 4.0, except for alopecia and infertility.
Secondary Outcomes
- Progression-free Survival (PFS)(From first date of study treatment until progression of disease or date of death from any cause, whichever comes first, assessed up to 34 months)
- Objective Response Rate (ORR)(Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 months)
- Disease Control Rate (DCR)(Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 months)
- Overall Survival (OS)(From study start until date of death from any cause, assessed up to 34 months)
- Best Overall Response (BOR)(Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 months)
- Clinical Benefit Rate (CBR)(Date of CR, PR, or dSD to date of PD or death (whichever was first), assessed up to 34 months)