Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Carcinoma

Adenocarcinoma

Carcinoma, Transitional Cell

Carcinoma, Squamous Cell

Cystadenocarcinoma, Serous

Adenocarcinoma, Clear Cell

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Cystic, Mucinous, and Serous

Transitional Cell Carcinoma

Adenocarcinoma of the Appendix

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Tyrosine Kinase Inhibitors

Nintedanib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Don Dizon

This phase II trial studies the side effects and how well nintedanib works in treating patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

PRIMARY OBJECTIVES:

I. To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free without going on a subsequent therapy against the disease for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with BIBF 1120 (nintedanib).

II. To determine the nature and degree of toxicity of BIBF 1120 in this cohort of patients.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with BIBF 1120.

OUTLINE:

Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of BIBF 1120 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

The incidence of adverse events (grade 3 or higher) as assessed by the National Cancer Institute CTCAE version 4.0

Complete and Partial Tumor Response by RECIST 1.1

Whether or not the patient survived progression-free for at least 6 months.

The observed length of life from entry into the study to death or the date of last contact.

the period of progression free survival for patients with persistent or recurrent endometrial cancer treated with study drug.

National Cancer Institute (NCI)

Gynecologic Oncology Group

Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Nintedanib: Given PO

Treatment (Nintedanib)

Age, Continuous

30-39 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

Linda Gedeon for Michael Sill, PhD

Leukopenia

Neutropenia

Anemia

Other Investigations

Nausea

Vomiting

Other Gastrointestinal

General & Administration site

Infections/infestations

Metabolism/nutrition

Musculoskeletal/connective tissue

Psychiatric

Renal/Urinary

Respiratory/thoracic/mediastinal

Vascular Disorders

Patients on study who experienced adverse events (Grade 3 or higher)

Number of Participants With Adverse Events

Objective Tumor Response

Progression-free Survival > 6 Months

Overall Survival

The time in months that a patient survived progression-free.

Progression Free Survival

Overall Study

Spots Global Cancer Trial Database for malignant uterine corpus mixed epithelial and mesenchymal neoplasm