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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03005015
Other study ID # EORTC-1528
Secondary ID
Status Withdrawn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Status Withdrawn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. completion date
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


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
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