Lenvatinib in Second Line Endometrial Carcinoma

Endometrial Neoplasms Clinical Trial

Official title:

A Randomized Phase II Study of Lenvatinib Versus Doxorubicin in Second Line Advanced or Recurrent Endometrial Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03005015
• Other study ID #: EORTC-1528
• Status: Withdrawn
• Phase: Phase 2
• First received: August 18, 2016
• Last updated: December 23, 2016
• Start date: January 2017

Study information

• Verified date: December 2016
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Drug:
• Lenvatinib

• Doxorubicin

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	PFS assessed by Response Evaluation Criteria in Solid Tumors (RECIST	2.5 years	No