Lenvatinib in Second Line Endometrial Carcinoma

NCT ID: NCT03005015

Last Updated: 2016-12-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31

Brief 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.

Conditions

Endometrial Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenvatinib

Lenvatinib 24 mg orally every day. Treatment is continued until unacceptable toxicity, progressive disease or patient withdrawal

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

Doxorubicin

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.

Group Type: ACTIVE_COMPARATOR

Doxorubicin

Intervention Type: DRUG

Interventions

Lenvatinib

Intervention Type: DRUG

Doxorubicin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Casado

Role: STUDY_CHAIR

Hospital Universitario San Carlos, Madrid, Spain

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

EORTC-1528

Identifier Type: -

Identifier Source: org_study_id