Trial Outcomes & Findings for Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma . (NCT NCT02788006)

Last Updated: 2024-02-23

Results Overview

Tumor control rate is defined as the percentage of patients with complete tumor response, partial tumor response, or tumor stability on regorafenib therapy at 2 months after initiation of therapy as determined by the investigator per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1 criteria) for target lesions and assessed by CT-Scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stability : neither complete or partial response nor progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

2 months after the start of treatment

Results posted on

2024-02-23

Participant Flow

Between January 2016 to April 2017, 43 patients were enrolled in the trial by 25 centers in France.

Before enrollement, standard examinations (biological, clinical, ECG) as well as geriatric questionnaires were done. In terms of imaging, abdominal and thoracic computed tomography scan or MRI were also done.

Participant milestones

Participant milestones
Measure	Regorafenib 160 mg Regorafenib monotherapy at an initial dose of 160 mg once daily orally (21 days on, 7 days off treatment)
Overall Study STARTED	43
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Regorafenib 160 mg Regorafenib monotherapy at an initial dose of 160 mg once daily orally (21 days on, 7 days off treatment)
Overall Study Patient not treated	1

Baseline Characteristics

Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regorafenib 160 mg n=42 Participants Regorafenib monotherapy at an initial dose of 160 mg once daily orally (21 days on, 7 days off treatment)
Age, Continuous	77.9 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	42 Participants n=5 Participants
Region of Enrollment France	42 participants n=5 Participants
Koehne Score Low	16 Participants n=5 Participants
Koehne Score Intermediate	22 Participants n=5 Participants
Koehne Score High	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months after the start of treatment

Outcome measures

Outcome measures
Measure	Regorafenib 160 mg n=35 Participants Regorafenib 160 mg
Percentage of Patients With a Tumoral Control Rate at 2 Months	31.4 Percentage of patients Interval 18.7 to 46.6

SECONDARY outcome

Timeframe: Up to approximatively 1 year after the end of the treatment

Population: All patients included in the study and who have been treated with regorafenib

Overall survival was defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news wastaken into account. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.

Outcome measures

Outcome measures
Measure	Regorafenib 160 mg n=42 Participants Regorafenib 160 mg
Overall Survival	7.5 months Interval 5.5 to 10.6

Adverse Events

Regorafenib 160 mg

Serious events: 17 serious events

Other events: 42 other events

Deaths: 36 deaths

Serious adverse events

Serious adverse events
Measure	Regorafenib 160 mg n=42 participants at risk Regorafenib monotherapy at an initial dose of 160 mg once daily orally (21 days on, 7 days off treatment)
Vascular disorders Pulmonary embolism	2.4% 1/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Injury, poisoning and procedural complications Fall	7.1% 3/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Cardiac disorders Hypertension	4.8% 2/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Cardiac disorders Haematoma	2.4% 1/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Cardiac disorders Tachycardia	2.4% 1/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Nervous system disorders Cerebrovascular ischemia	4.8% 2/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Nervous system disorders Headache	2.4% 1/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Nervous system disorders Neuropathy peripheral	2.4% 1/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
General disorders Fatigue	11.9% 5/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Gastrointestinal disorders Diarrhoea	2.4% 1/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Metabolism and nutrition disorders Deshydratation	2.4% 1/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.

Other adverse events

Other adverse events
Measure	Regorafenib 160 mg n=42 participants at risk Regorafenib monotherapy at an initial dose of 160 mg once daily orally (21 days on, 7 days off treatment)
Gastrointestinal disorders Constipation	31.0% 13/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations Aspartate aminotransferase increased	50.0% 21/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations Alanine aminotransferase increased	28.6% 12/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations Total Bilirubin increased	52.4% 22/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations Gamma-glutamyltransferase increased	73.8% 31/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations White blood cell count decreased	9.5% 4/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations Lipase increased	16.7% 7/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations Neutrophils decreased	9.5% 4/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations Lymphocytes decreased	7.1% 3/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations Phosphatases Alcalines increased	50.0% 21/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Investigations Platelets decreased	47.6% 20/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Cardiac disorders Hypertension	28.6% 12/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Blood and lymphatic system disorders Anemia	45.2% 19/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Respiratory, thoracic and mediastinal disorders Dysphonia	26.2% 11/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Nervous system disorders Headache	7.1% 3/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Nervous system disorders Dysgueusia	9.5% 4/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
General disorders Fatigue	81.0% 34/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
General disorders Pyrexia	16.7% 7/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Gastrointestinal disorders Diarrhoea subjects	40.5% 17/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Gastrointestinal disorders Abdominal pain	21.4% 9/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Gastrointestinal disorders Stomatitis	16.7% 7/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Gastrointestinal disorders Nausea	11.9% 5/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Renal and urinary disorders Proteinuria	21.4% 9/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	42.9% 18/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 3/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 6/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Metabolism and nutrition disorders Hypokaliemia	7.1% 3/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Endocrine disorders Hypothyroidism	21.4% 9/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Metabolism and nutrition disorders Anorexia	54.8% 23/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Metabolism and nutrition disorders Hyperkalaemia	7.1% 3/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Metabolism and nutrition disorders Hypoalbuminaemia	7.1% 3/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Metabolism and nutrition disorders Hypocalcaemia	35.7% 15/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Metabolism and nutrition disorders Hypomagnesaemia	11.9% 5/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Musculoskeletal and connective tissue disorders Hyponatremia	21.4% 9/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.
Metabolism and nutrition disorders Hypophosphataemia	21.4% 9/42 • Up to the end of treatment. Treatement was usually stopped after 70 days of treatments. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.

Additional Information

Karine Le Malicot

Fédération Francophone de Cancérologie Digestive

Phone: +33 3 80 39 34 79

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place