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

NCT01731925 | Unknown Phase 2 DMC

• 2 other identifiers: SUNLAND D12-012012-001098-94
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 20

Brief Summary

Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with neuroendocrine tumors.

Conditions

Carcinoid Tumors

Keywords

midgut carcinoid tumors; progressive; advanced; metastatic

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

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: Lanreotide; Drug: 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: Lanreotide; Drug: Placebo (for sunitinib)

Interventions

Lanreotide DRUG

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.

Placebo; Sunitinib

Placebo (for sunitinib) DRUG

Placebo

Sunitinib DRUG

Sunitinib 37.5 mg daily

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• HIAA levels superior to 1.5ULN as measured in each individual centre.
• Disease that is not amenable to surgery with curative intent.
• Presence of at least one measurable target lesion for further evaluation according to RECIST v1.1
• Adequate organ function
• ECOG Performance status 0 or 1.
• Life expectancy superior or equal to 3 months.
• Age superior or equal to 18 years.
• Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment. Breast feeding is not allowed. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
• Able to swallow oral compound.
• Signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial prior to enrollment.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
• Registration in a national health care system (CMU included).

You may not qualify if:

• Patients with undifferentiated, poorly differentiated gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, bronchial carcinoid tumors.
• Patients with carcinoid tumors with the presence of an obstructive intestinal tumor.
• Patients with uncontrolled cardiac complication as part of their carcinoid syndrome.
• Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent
• Current treatment with dose superior or equal to 120 mg per month of lanreotide
• Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors such as everolimus or temsirolimus is permitted.
• Patients who stopped everolimus treatment was less than 4 weeks prior to randomization.
• Patients with concomitant treatment with interferon.
• Patients previously treated with chemotherapy, loco-regional therapy (e.g., chemoembolization) or interferon with last administration less than 6 weeks prior to randomization or with toxicity not resolved to less or equal grade 1 at randomization.
• Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
• Treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days, respectively prior to study drug administration.
• Concomitant treatment with therapeutic doses of anticoagulants
• Concomitant treatment with a drug having proarrhythmic potential
• Unstable systemic diseases including uncontrolled hypertension or active uncontrolled infections.
• Current treatment on another clinical trial.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead
• Pfizer: collaborator
• Ipsen: collaborator

Study Sites (20)

Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

Institut Jules Bordet

Brussels, Belgium

Location

ULB Erasme

Brussels, Belgium

Location

UZ Antwerpen

Edegem, Belgium

Location

UZ Gent

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Hôpital Saint André

Bordeaux, 33075, France

Location

Hôpital Beaujon

Clichy, 92118, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Hopital Saint Vincent de Paul

Lille, 59020, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

CHU La Timone

Marseille, 13005, France

Location

Hôpital St Antoine

Paris, 75012, France

Location

CHU Cochin

Paris, France

Location

Hôpital Pitié Salpêtrière

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

CHU Robert Debré

Reims, France

Location

CHU Pontchaillou

Rennes, France

Location

CHU Rouen

Rouen, France

Location

CHRU Trousseau

Tours, France

Location

MeSH Terms

Conditions

Carcinoid Tumor; Neoplasm Metastasis

Interventions

lanreotide; Sunitinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pascal HAMMEL, MD

  Hôpital Beaujon

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

BE (6); FR (14)