Trial Outcomes & Findings for Regorafenib in Metastatic Colorectal Cancer (NCT NCT02466009)

NCT ID: NCT02466009

Last Updated: 2024-09-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: From the date of study entry until 30 days after the last dose of study treatment.
• Results posted on: 2024-09-04

Participant Flow

31 people were screened and 4 failed screening.

Participant milestones

Measure	Regorafenib 120 mg qd, 3 weeks on/1 week off (each cycle is 28 days) Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\< 30% fat) breakfast. Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Regorafenib in Metastatic Colorectal Cancer

Baseline characteristics by cohort

Measure	Regorafenib n=27 Participants 120 mg qd, 3 weeks on/1 week off (each cycle is 28 days) Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\< 30% fat) breakfast. Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
Age, Continuous	74 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants
Number of concomitant medications	13 number of concomitant medications n=5 Participants

PRIMARY outcome

Timeframe: From the date of study entry until 30 days after the last dose of study treatment.

Outcome measures

Measure	Regorafenib n=27 Participants 120 mg qd, 3 weeks on/1 week off (each cycle is 28 days) Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\< 30% fat) breakfast. Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.	20 Participants

SECONDARY outcome

Timeframe: From the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years.

Efficacy outcomes will be response rate (RR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). A participant's best response will be classified per RECIST (Response evaluation criteria in solid tumors) criteria into complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). If a participant's best response was complete response, partial response, or stable disease they were classified as responding to treatment.

Outcome measures

Measure	Regorafenib n=27 Participants 120 mg qd, 3 weeks on/1 week off (each cycle is 28 days) Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\< 30% fat) breakfast. Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
Percentage of Subjects Who Responded to Study Treatment	3.7 percentage of participants

SECONDARY outcome

Timeframe: baseline and week 4

The FACT-C instrument is an 11 question survey that asks general questions about the participants digestive system. The instrument scores range from 0-44 with higher scores indicating digestive problems.

Outcome measures

Measure	Regorafenib n=16 Participants 120 mg qd, 3 weeks on/1 week off (each cycle is 28 days) Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\< 30% fat) breakfast. Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
Mean Difference in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Instrument	-0.82 score on a scale Interval -18.33 to 23.33

OTHER_PRE_SPECIFIED outcome

Timeframe: week 4

Outcome measures

Outcome data not reported

Adverse Events

Regorafenib

Serious events: 0 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Regorafenib n=27 participants at risk 120 mg qd, 3 weeks on/1 week off (each cycle is 28 days) Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\< 30% fat) breakfast. Regorafenib: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	14.8% 4/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Renal and urinary disorders Acute kidney injury	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Psychiatric disorders Confusion	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Nervous system disorders Dizziness	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Nervous system disorders Presyncope	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Nervous system disorders Syncope	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	7.4% 2/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Metabolism and nutrition disorders Anorexia	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Metabolism and nutrition disorders Dehydration	7.4% 2/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Investigations Alanine aminotransferase increased	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Investigations Aspartate aminotransferase increased	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Investigations Blood bilirubin increased	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Investigations Investigations - Other	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Cardiac disorders Sinus bradycardia	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Gastrointestinal disorders Abdominal pain	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Gastrointestinal disorders Gastrointestinal disorders - Other	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Gastrointestinal disorders Nausea	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Gastrointestinal disorders Rectal hemorrhage	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Gastrointestinal disorders Vomiting	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
General disorders Edema limbs	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
General disorders Fatigue	37.0% 10/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Vascular disorders hypertension	59.3% 16/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Vascular disorders Thromboembolic event	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Metabolism and nutrition disorders Hypocalcemia	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Metabolism and nutrition disorders Hyponatremia	18.5% 5/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Metabolism and nutrition disorders Hypophosphatemia	7.4% 2/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Injury, poisoning and procedural complications Intestinal stoma site bleeding	3.7% 1/27 • 2 years Grade 3-5 non-serious adverse events were reported.
Blood and lymphatic system disorders Anemia	11.1% 3/27 • 2 years Grade 3-5 non-serious adverse events were reported.

Additional Information

Aram Hezel

University of Rochester

Phone: 585-275-5823

Email: Aram_Hezel@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place