Trial Outcomes & Findings for Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer (NCT NCT02278783)

Last Updated: 2017-10-06

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Patients will be checked for PFS after 6 months on treatment

Results posted on

2017-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=1 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Age, Continuous	71 years n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: Patients will be checked for PFS after 6 months on treatment

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

Outcome measures

Outcome measures
Measure	All Patients n=1 Participants
6 Month Progression Free Survival (PFS)	1 participants

PRIMARY outcome

Timeframe: Patients will remain on treatment for approximately 4-6 months on average.

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.

Outcome measures

Outcome measures
Measure	All Patients n=1 Participants
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	1 participants

SECONDARY outcome

Timeframe: At 6 months patients will be checked for PFS, and compared to the expected probability of the patient being alive and progression-free for at least 6 months

Population: Study was terminated early, no analysis performed.

To estimate progression free survival for patients treated with this regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Scans will be done every 2 cycles (every 2 months) for disease assessment. Patients on average will be on treatment for 4-6 months

Population: Study was terminated early, no analysis performed.

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

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Patients n=1 participants at risk
Blood and lymphatic system disorders anemia	100.0% 1/1
Cardiac disorders tachycardia	100.0% 1/1
Gastrointestinal disorders oral mucositis	100.0% 1/1
Gastrointestinal disorders diarrhea	100.0% 1/1
General disorders chills	100.0% 1/1
Investigations platelet count decrease	100.0% 1/1
Investigations creatinine increased	100.0% 1/1
Investigations AST increased	100.0% 1/1
Investigations weight loss	100.0% 1/1
Metabolism and nutrition disorders hyponatremia	100.0% 1/1
Metabolism and nutrition disorders hyperglycemia	100.0% 1/1
Nervous system disorders headache	100.0% 1/1
Nervous system disorders dizziness	100.0% 1/1
Respiratory, thoracic and mediastinal disorders hoarseness	100.0% 1/1
Respiratory, thoracic and mediastinal disorders cough	100.0% 1/1
Respiratory, thoracic and mediastinal disorders epistaxis	100.0% 1/1
Skin and subcutaneous tissue disorders palmar-plantar eythrodysesthesia syndrome	100.0% 1/1
Skin and subcutaneous tissue disorders macular rash	100.0% 1/1
Vascular disorders hypertension	100.0% 1/1

Additional Information

Theresa Werner

Huntsman Cancer Institute

Phone: 801-587-3486

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place