Trial Outcomes & Findings for A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET) (NCT NCT02288377)

Last Updated: 2023-01-18

Results Overview

The primary endpoint for this phase II study was the proportion of pts alive and progression-free at 6 months after randomisation, evaluated according to the results of the imaging assessment done by the investigator in line with RECIST 1.1 criteria.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

53 participants

Primary outcome timeframe

6 months

Results posted on

2023-01-18

Participant Flow

Fifty-three pts were randomised in 15 centres between January 2015 and October 2018.

The study was terminated prematurely because of slow recruitment.

Participant milestones

Participant milestones
Measure	Placebo Patients will receive placebo every 28 days until disease progression	Lanreotide Patients will receive lanreotide 120 mg every 28 days until disease progression
Overall Study STARTED	26	27
Overall Study COMPLETED	25	27
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=26 Participants Patients will receive placebo every 28 days until disease progression	Lanreotide n=27 Participants Patients will receive lanreotide 120 mg every 28 days until disease progression	Total n=53 Participants Total of all reporting groups
Age, Continuous	61.2 years STANDARD_DEVIATION 12.45 • n=26 Participants	65.22 years STANDARD_DEVIATION 10.30 • n=27 Participants	63.25 years STANDARD_DEVIATION 11.47 • n=53 Participants
Sex: Female, Male Female	13 Participants n=26 Participants	12 Participants n=27 Participants	25 Participants n=53 Participants
Sex: Female, Male Male	13 Participants n=26 Participants	15 Participants n=27 Participants	28 Participants n=53 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Belgium	0 participants n=26 Participants	1 participants n=27 Participants	1 participants n=53 Participants
Region of Enrollment United Kingdom	1 participants n=26 Participants	1 participants n=27 Participants	2 participants n=53 Participants
Region of Enrollment France	25 participants n=26 Participants	25 participants n=27 Participants	50 participants n=53 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 2 patients without tumor evaluation at cycle 4 nor cycle 7 were not evaluable for the primary criterion

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Patients will receive placebo every 28 days until disease progression	Lanreotide n=26 Participants Patients will receive lanreotide 120 mg every 28 days until disease progression
Proportion of Patients Alive and Progression-free at 6 Months	13 Participants	19 Participants

SECONDARY outcome

Timeframe: up to 2 years

Population: Outcomes was evaluated on patients randomized and receiving at least one dose of treatment

The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a nontarget lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Patients will receive placebo every 28 days until disease progression	Lanreotide n=27 Participants Patients will receive lanreotide 120 mg every 28 days until disease progression
Progression-Free Survival	7.6 Months Interval 3.0 to 9.0	19.4 Months Interval 7.6 to 32.6

SECONDARY outcome

Timeframe: 2 years after the end of the treatment

Population: The outcome was evaluated on randomized patients who received at least one dose of treatment

Overall survival considered all deaths, and time was calculated from randomisation to death.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Patients will receive placebo every 28 days until disease progression	Lanreotide n=27 Participants Patients will receive lanreotide 120 mg every 28 days until disease progression
Overall Survival	86.1 Percentage of patients alive Interval 62.1 to 95.4	95.0 Percentage of patients alive Interval 69.5 to 99.3

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 6 other events

Deaths: 7 deaths

Lanreotide

Serious events: 5 serious events

Other events: 9 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=25 participants at risk Patients will receive placebo every 28 days until disease progression	Lanreotide n=27 participants at risk Patients will receive lanreotide 120 mg every 28 days until disease progression
Metabolism and nutrition disorders Hypokalaemia	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	0.00% 0/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Constipation	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	0.00% 0/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Small intestinal obstruction	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	0.00% 0/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
General disorders Pyrexia	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Hepatobiliary disorders Cholangitis and Malignant biliary obstruction	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Hepatobiliary disorders Cholangitis and Cholecystitis acute	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)

Other adverse events

Other adverse events
Measure	Placebo n=25 participants at risk Patients will receive placebo every 28 days until disease progression	Lanreotide n=27 participants at risk Patients will receive lanreotide 120 mg every 28 days until disease progression
Gastrointestinal disorders Abdominal Pain	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Gastrointestinal haemorrhage	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Diarrhoea	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	7.4% 2/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Vomiting	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
General disorders Asthenia	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	7.4% 2/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Hepatobiliary disorders Cholangitis	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	0.00% 0/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Hepatobiliary disorders Cholecystitis acute	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	0.00% 0/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Hepatobiliary disorders Malignant biliary obstruction	4.0% 1/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	0.00% 0/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/25 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)	3.7% 1/27 • Up to the end of treatment, on average of 24 months Toxicities were collected before each injection of treatment up to the end of the treatment each 28 days. The study treatment was given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)

Additional Information

Karine Le Malicot

FFCD

Phone: + 33 3 80 39 34 79

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place