Trial · NCT02264665

OPALINE : A Study Of Morbidity And Mortality At 2 Years

NCT02264665, Completed, Pfizer; results first posted 2023-11-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. OPALINE : A Study Of Morbidity And Mortality At 2 Years. Trials, record NCT02264665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02264665

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: OPALINE : A Study Of Morbidity And Mortality At 2 Years
NCT number: NCT02264665
Status: Completed
Enrollment: 144 participants, actual
Lead sponsor: Pfizer
Conditions: Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
Interventions: sunitinib, everolimus, chemotherapies recommended in france
First posted: 2014-10-15
Last updated: 2023-11-13
Results first posted: 2023-11-13

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion	At 2 years of prospective follow-up	PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of disease progression (PD) or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.
Primary	PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	At 2 years of prospective follow-up	PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of PD or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.
Primary	Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion	At 2 years of prospective follow-up	OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.
Primary	OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion	At 2 years of prospective follow-up	OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.
Primary	Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion	During 2 years of prospective follow-up
Primary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study	During 2 years of prospective follow-up	AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that: led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. Relatedness to treatment was assessed by investigator. Per CTCAE 4.0, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4=Life-threatening events Grade 5 (Death) events=death related to an AE. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
Primary	Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study	During 2 years of prospective follow-up	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
Primary	Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study	During 2 years of prospective follow-up	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events leading to death are reported in this outcome measure. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
Secondary	Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	During 2 years of prospective follow-up
Secondary	Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	During 2 years of prospective follow-up	Frequency = number of tumor assessment visits /(\[last visit date - baseline date\]/365.25).

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion	At 2 years of prospective follow-up	FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.	Percentage of participants	NUMBER
PRIMARY	PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	At 2 years of prospective follow-up	FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.	Percentage of participants	NUMBER
PRIMARY	Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion	At 2 years of prospective follow-up	FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here, Overall Number of Participants signifies number of participants evaluable for this outcome measure.	Percentage of participants	NUMBER
PRIMARY	OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion	At 2 years of prospective follow-up	FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here, Overall Number of Participants signifies number of participants evaluable for this outcome measure.	Percentage of participants	NUMBER
PRIMARY	Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion	During 2 years of prospective follow-up	Safety analysis set included participants who received at least one dose of the documented treatment in the study (targeted therapy or other treatment). If the participant was prevalent, the treatment must still be ongoing at the time of inclusion in the study and if the participant was incident, the treatment must be started at or after inclusion in the study. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study	During 2 years of prospective follow-up	Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study	During 2 years of prospective follow-up	Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study	During 2 years of prospective follow-up	Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	During 2 years of prospective follow-up	FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.	Visits	MEAN
SECONDARY	Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	During 2 years of prospective follow-up	FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group154

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion	Everolimus (Targeted Therapy) at Inclusion	26.5	95% Confidence Interval 10.3 to 46.0	Percentage of participants
Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion	Sunitinib (Targeted Therapy) at Inclusion	19.3	95% Confidence Interval 4.6 to 41.4	Percentage of participants
Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion	Chemotherapy (Other Treatment) at Inclusion	36.5	95% Confidence Interval 13.8 to 60.0	Percentage of participants
Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion	Somatostatin Analogues (Other Treatment) at Inclusion	38.6	95% Confidence Interval 16.0 to 61.0	Percentage of participants
Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion	Metabolic Radiotherapy (Other Treatment) at Inclusion	NA	95% Confidence Interval NA to NA	Percentage of participants
PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	Targeted Therapy at Inclusion	19.9	95% Confidence Interval 9.2 to 33.4	Percentage of participants
PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion	Other Treatments at Inclusion	29.0	95% Confidence Interval 14.7 to 45.0	Percentage of participants
Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion	Everolimus (Targeted Therapy) at Inclusion	60.2	95% Confidence Interval 37.6 to 76.8	Percentage of participants
Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion	Sunitinib (Targeted Therapy) at Inclusion	68.4	95% Confidence Interval 37.8 to 86.2	Percentage of participants
Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion	Chemotherapy (Other Treatment) at Inclusion	69.6	95% Confidence Interval 52.6 to 81.6	Percentage of participants

1 to 10 of 154Source ClinicalTrials.gov

See all 154 results by group

Participant flow35

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Everolimus (Targeted Therapy) at Inclusion	35
Overall Study	STARTED	Sunitinib (Targeted Therapy) at Inclusion	23
Overall Study	STARTED	Chemotherapy (Other Treatment) at Inclusion	52
Overall Study	STARTED	Somatostatin Analogues (Other Treatment) at Inclusion	30
Overall Study	STARTED	Metabolic Radiotherapy (Other Treatment) at Inclusion	1
Overall Study	STARTED	Interferon-alpha (Other Treatment) at Inclusion	0
Overall Study	STARTED	Treatment Not Documented	3
Overall Study	Reference Set (Full Analysis Set)	Everolimus (Targeted Therapy) at Inclusion	32
Overall Study	Reference Set (Full Analysis Set)	Sunitinib (Targeted Therapy) at Inclusion	23
Overall Study	Reference Set (Full Analysis Set)	Chemotherapy (Other Treatment) at Inclusion	50

1 to 10 of 35Source ClinicalTrials.gov

See all 35 participant flow

Adverse events1,710

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Asthenia	General disorders	Everolimus During Study	5	52
other	Asthenia	General disorders	Sunitinib During Study	6	36
other	Asthenia	General disorders	Chemotherapy During Study	24	82
other	Asthenia	General disorders	Somatostatin Analogues During Study	8	65
other	Asthenia	General disorders	Metabolic Radiotherapy During Study	1	11
other	Asthenia	General disorders	Other Than Study Treatment During Study	2	16
other	Mucosal inflammation	General disorders	Everolimus During Study	8	52
other	Mucosal inflammation	General disorders	Sunitinib During Study	3	36
other	Mucosal inflammation	General disorders	Chemotherapy During Study	2	82
other	Mucosal inflammation	General disorders	Somatostatin Analogues During Study	3	65

1 to 10 of 1,710Source ClinicalTrials.gov

See all 1,710 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Everolimus During Study	4	52
Total, all-cause mortality	Sunitinib During Study	3	36
Total, all-cause mortality	Chemotherapy During Study	15	82
Total, all-cause mortality	Somatostatin Analogues During Study	14	65
Total, all-cause mortality	Metabolic Radiotherapy During Study	2	11
Total, all-cause mortality	Other Than Study Treatment During Study	1	16
Total, other adverse events	Everolimus During Study	39	52
Total, other adverse events	Sunitinib During Study	29	36
Total, other adverse events	Chemotherapy During Study	56	82
Total, other adverse events	Somatostatin Analogues During Study	41	65

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35419649	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Targeted Therapy at Inclusion vs Other Treatments at Inclusion: Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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