Clinical trial · Interventional
Lenvatinib in Second Line Endometrial Carcinoma
A Randomized Phase II Study of Lenvatinib Versus Doxorubicin in Second Line Advanced or Recurrent Endometrial Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): supporting company (Eisai) withdrew their interest
Summary
Brief summary (as posted)
The primary objective of this multicenter, randomized phase II trial is to assess the efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to doxorubicin in advanced or recurrent endometrial cancer. The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib activity and establishing a cutoff value as potential selection criteria for phase III. Other secondary objectives are to assess the tolerability and safety of lenvatinib in this setting and overall survival, response and disease control.
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 |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lenvatinib
- description
- Lenvatinib 24 mg orally every day. Treatment is continued until unacceptable toxicity, progressive disease or patient withdrawal
- interventionNames
- Drug: Lenvatinib
- type
- ACTIVE_COMPARATOR
- label
- Doxorubicin
- description
- Doxorubicin 60 mg/m² iv bolus every 3 weeks. Treatment is continued for a maximum of 6 cycles or until unacceptable toxicity, progressive disease or patient withdrawal.
- interventionNames
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects age ≥18 years at the time of informed consent * World Health Organization (WHO) Performance Status of 0 or 1 * Patients with histologically confirmed endometrial cancer including serous-papillary and clear cell histologies. Uterine carcinosarcomas are allowed. * Radiographic evidence of disease progression according to RECIST 1.1 after 1 prior systemic, platinum-based chemotherapy regimen for metastatic or primary unresectable endometrial carcinoma for which no surgical or radiotherapy treatment options exist. * Patients with disease progression following platinum-based chemotherapy administered as either adjuvant or neoadjuvant treatment are also eligible. * Patients may have received prior radiotherapy and / or adjuvant chemotherapy for early high-risk disease * Patients may not have received prior treatment with anthracyclines * Blood samples available for retrospective central assessment of Ang-2 level * Patients may have had prior therapy providing the following conditions are met: * Surgery and radiation therapy: wash-out period of 14 days and subjects must have recovered adequately from any toxicity and/or complications from radiotherapy and major surgery prior to starting therapy. * Systemic anti-tumor therapy or any investigational agent: wash-out period of 21 days (or 5 x half-life) * Recovery from any toxic effects of prior therapy to ≤ Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.) except alopecia * Adequate contraceptive measures * Signed written informed consent Exclusion Criteria: * Inadequate hematologic, renal and hepatic functions * Abnormal cardiac function
References
Publications (0)
Data not yet available