Clinical trial · Interventional
A Study of E7080 in Subjects With Advanced Thyroid Cancer
A Phase 2 Study of E7080 in Subjects With Advanced Thyroid Cancer
NCT01728623CI-TRIAL-00046644completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E7080 capsule | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- E7080
- interventionNames
- Drug: E7080 capsule
Primary outcomes (1)
- measure
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
- timeFrame
- Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years
- description
- 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 (6)
- measure
- Progression-free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion criteria 1. Histologically or clinically diagnosed with thyroid cancer 2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2 3. Adequate laboratory values/organ function tests Exclusion criteria Participants with following complication or disease history 1. Brain metastasis 2. Systemic severe infection 3. Significant cardiovascular impairment 4. QTc greater than 480 milliseconds 5. Active hemoptysis 6. Bleeding or thrombotic disorders 7. Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour urine collection for quantitative assessment of proteinuria 8. Gastrointestinal malabsorption or any other condition in the opinion of the investigator that might affect the absorption of E7080 9. Major surgery within 3 weeks before enrollment 10. With co-existing effusion requiring drainage
References
Publications (2)
- DERIVEDTakahashi S, Kiyota N, Yamazaki T, Chayahara N, Nakano K, Inagaki L, Toda K, Enokida T, Minami H, Imamura Y, Fukuda N, Sasaki T, Suzuki T, Ikezawa H, Dutcus CE, Tahara M. A Phase II study of the safety and efficacy of lenvatinib in patients with advanced thyroid cancer. Future Oncol. 2019 Mar;15(7):717-726. doi: 10.2217/fon-2018-0557. Epub 2019 Jan 14. PMID 30638399
- DERIVEDTahara M, Kiyota N, Yamazaki T, Chayahara N, Nakano K, Inagaki L, Toda K, Enokida T, Minami H, Imamura Y, Sasaki T, Suzuki T, Fujino K, Dutcus CE, Takahashi S. Lenvatinib for Anaplastic Thyroid Cancer. Front Oncol. 2017 Mar 1;7:25. doi: 10.3389/fonc.2017.00025. eCollection 2017. PMID 28299283