Back to resultsLenvatinib in Second Line Endometrial Carcinoma
Primary Purpose
Endometrial Neoplasms
Status
Withdrawn
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Lenvatinib
Doxorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Neoplasms
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
Sites / Locations
- Centre Hospitalier Universitaire Vaudois
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lenvatinib
Doxorubicin
Arm Description
Lenvatinib 24 mg orally every day. Treatment is continued until unacceptable toxicity, progressive disease or patient withdrawal
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.
Outcomes
Primary Outcome Measures
Progression free survival (PFS)
PFS assessed by Response Evaluation Criteria in Solid Tumors (RECIST
Secondary Outcome Measures
Full Information
NCT ID
NCT03005015
First Posted
August 18, 2016
Last Updated
December 23, 2016
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT03005015
Brief Title
Lenvatinib in Second Line Endometrial Carcinoma
Official Title
A Randomized Phase II Study of Lenvatinib Versus Doxorubicin in Second Line Advanced or Recurrent Endometrial Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
supporting company (Eisai) withdrew their interest
Study Start Date
January 2017 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lenvatinib
Arm Type
Experimental
Arm Description
Lenvatinib 24 mg orally every day. Treatment is continued until unacceptable toxicity, progressive disease or patient withdrawal
Arm Title
Doxorubicin
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS assessed by Response Evaluation Criteria in Solid Tumors (RECIST
Time Frame
2.5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Casado
Organizational Affiliation
Hospital Universitario San Carlos, Madrid, Spain
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Lenvatinib in Second Line Endometrial Carcinoma
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