Lenvatinib in Second Line Endometrial Carcinoma

NCT03005015 | Withdrawn Phase 2 DMC

• 1 other identifier: EORTC-1528
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  PFS assessed by Response Evaluation Criteria in Solid Tumors (RECIST

  2.5 years

Study Arms (2)

Lenvatinib

EXPERIMENTAL

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

Drug: Lenvatinib

Doxorubicin

ACTIVE COMPARATOR

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.

Drug: Doxorubicin

Interventions

Lenvatinib DRUG

Lenvatinib

Doxorubicin DRUG

Doxorubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inadequate hematologic, renal and hepatic functions
• Abnormal cardiac function

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

lenvatinib; Doxorubicin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Antonio Casado

  Hospital Universitario San Carlos, Madrid, Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: July 1, 2020
• Last Updated: December 29, 2016

Record last verified: 2016-12

Locations

CH (1)