Trials Sponsors Conditions Drugs Pricing

Conditions

Carcinoid Tumors

Keywords

midgut carcinoid tumorsprogressiveadvancedmetastatic

Outcome Measures

Primary Outcomes (1)

Progression free survival (PFS)
To evaluate the efficacy of the combination of sunitinib malate with lanreotide acetate and of placebo with lanreotide acetate regarding progression-free-survival (PFS) as assessed by the investigator, in patients suffering from progressive, advanced/metastatic midgut carcinoid tumors.
time from date of randomization to first progression of disease (PD) or death for any reason in the absence of documented PD, assessed up to 3 years after the beginning of the study

Secondary Outcomes (7)

Overall survival (OS)
time from date of randomization to date of death, assessed up to 3 years after the beginning of the study
Objective response (OR)
from randomization until disease progression, assessed up to 3 years after the beginning of the study
Duration of response (DR)
time from CR or PR to objective tumor progression or to death due to any cause, whichever occurs first, assessed up to 3 years after the beginning of the study
Time to tumor response (TTR)
time from date of randomization to first documentation of objective tumor response that is subsequently confirmed.assessed up to 3 years after the beginning of the study
Biological responses
from baseline to end of treatment, assessed up to 3 years after the beginning of the study
+2 more secondary outcomes

Study Arms (2)

Sunitinib

EXPERIMENTAL

Sunitinib 37.5 mg daily. Lanreotide at the dose of 120 mg will be injected every 28 days as the reference treatment to control the carcinoid syndrome in both arms.

Drug: LanreotideDrug: Sunitinib

Placebo

PLACEBO COMPARATOR

Placebo (for sunitinib). Lanreotide at the dose of 120 mg will be injected every 28 days as the reference treatment to control the carcinoid syndrome in both arms.

Drug: LanreotideDrug: Placebo (for sunitinib)

Interventions

LanreotideDrug

Lanreotide at the dose of 120 mg will be injected every 28 days as the reference treatment to control the carcinoid syndrome in both arms.

PlaceboSunitinib

Placebo (for sunitinib)Drug

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with midgut well-differentiated Grade 1-2 endocrine tumor.
Local, locally advanced or metastatic disease documented as progressive by RECIST v1.1. on CT-scan or MRI at baseline and within 12 months prior to baseline.

Sponsors & Collaborators

GERCOR - Multidisciplinary Oncology Cooperative Group
Otherlead
Pfizer
Industrycollaborator
Ipsen

Study Sites (20)

Cliniques Universitaires Saint Luc

Brussels, Belgium

Institut Jules Bordet

Brussels, Belgium

ULB Erasme

Brussels, Belgium

UZ Antwerpen

Edegem, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Hôpital Saint André

Bordeaux, 33075, France

Hôpital Beaujon

MeSH Terms

Conditions

Carcinoid TumorNeoplasm Metastasis

Interventions

lanreotideSunitinib

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplastic Processes

Study Officials

Pascal HAMMEL, MD
Hôpital Beaujon
PRINCIPAL INVESTIGATOR

Enrollment

44 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

January 7, 2013

Actual (reported)

A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Sunitinib

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Sunitinib

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations