Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Patients will be treated with Regorafenib 160 mg (4 x 40 mg tablets) daily for 21 days of a 28 day cycle (three weeks on drug, one week off) until disease progression or adverse effects prohibit further treatment

regorafenib

This will be a non-blinded, single arm study to test the efficacy of Regorafenib in patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer.

Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer

To evaluate the anti-tumor activity of Regorafenib as measured by progression free survival at 6 months in patients with recurrent gynecological cancers

To determine the nature and degree of toxicity of Regorafenib in this cohort of patients. Toxicity will be summarized by attribution: regorafenib-related adverse events grade 2 or higher will be reported.

To estimate progression free survival for patients treated with this regimen

To determine the frequency of clinical benefit (stable disease, partial, and complete response) according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria

Bayer

University of Utah

All Patients

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Theresa Werner

6 Month Progression Free Survival (PFS)

Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Study was terminated early, no analysis performed.

Estimate Progression Free Survival

Frequency of Clinical Benefit (Stable Disease, Partial and Complete Response)

Overall Study

Spots Global Cancer Trial Database for Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial