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Trial record 1 of 1 for:    NCT01731925
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A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors (SUNLAND)

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ClinicalTrials.gov Identifier: NCT01731925
Recruitment Status : Unknown
Verified January 2017 by GERCOR - Multidisciplinary Oncology Cooperative Group.
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2012
Last Update Posted : January 31, 2017
Sponsor:
Collaborators:
Pfizer
Ipsen
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Tracking Information
First Submitted Date  ICMJE November 19, 2012
First Posted Date  ICMJE November 22, 2012
Last Update Posted Date January 31, 2017
Actual Study Start Date  ICMJE January 7, 2013
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
Progression free survival (PFS) [ Time Frame: 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 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
  • Overall survival (OS) [ Time Frame: time from date of randomization to date of death, assessed up to 3 years after the beginning of the study ]
    To evaluate overall survival (OS) in sunitinib- and placebo-treated subjects.
  • Objective response (OR) [ Time Frame: from randomization until disease progression, assessed up to 3 years after the beginning of the study ]
    To evaluate objective response (OR) rate in sunitinib- and placebo-treated subjects.
  • Duration of response (DR) [ Time Frame: 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 ]
    To evaluate duration of response (DR) in sunitinib- and placebo-treated subjects in subjects achieving a response.
  • Time to tumor response (TTR) [ Time Frame: 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 ]
    To assess time to tumor response (TTR) for sunitinib- and placebo-treated subjects.
  • Biological responses [ Time Frame: from baseline to end of treatment, assessed up to 3 years after the beginning of the study ]
    To evaluate the best biological responses as assessed using serum chromogranin A and urine 5HIAA for sunitinib- and placebo-treated subjects.
  • Safety [ Time Frame: from visit 1 to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study ]
    To assess safety and tolerability of sunitinib in the study population.
  • Quality of life [ Time Frame: From screening to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study ]
    To assess Health related Quality of life (EORTC QLQ C-30).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid Tumors
Official Title  ICMJE A RANDOMIZED PHASE II DOUBLE-BLIND TRIAL OF SUNITINIB VERSUS PLACEBO IN COMBINATION WITH LANREOTIDE IN PATIENTS WITH PROGRESSIVE ADVANCED/METASTATIC MIDGUT CARCINOID TUMORS
Brief Summary Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with neuroendocrine tumors.
Detailed Description

With the exception of surgery for localized disease, there is presently a lack of available therapies with proven survival benefit for patients with neuroendocrine tumors (NET). Available treatment options for unresectable disease include the use of somatostatin analogs, which may relieve symptoms related to hormonal hypersecretion. The efficacy of cytotoxic chemotherapy in patients with metastatic carcinoid tumors is also limited. Combinations of either streptozocin and cyclophosphamide, or streptozocin and 5-fluorouracil, appear to be inactive, and both regimens are associated with substantial toxicity.

Receptor tyrosine kinases (RTKs) are implicated in deregulated/ autocrine proliferation and survival of solid and hematologic cancer cells. Sunitinib malate is an orally administered small molecule that inhibits the tyrosine kinase enzymatic activities of the receptors for VEGF and PDGF, and also blocks signalling through the KIT, FLT3 and RET pathways.

Therefore, sunitinib malate may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with NET.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Carcinoid Tumors
Intervention  ICMJE
  • Drug: Lanreotide
    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: Placebo (for sunitinib)
  • Drug: Sunitinib
    Sunitinib 37.5 mg daily
Study Arms  ICMJE
  • Experimental: Sunitinib
    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.
    Interventions:
    • Drug: Lanreotide
    • Drug: Sunitinib
  • Placebo Comparator: Placebo
    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.
    Interventions:
    • Drug: Lanreotide
    • Drug: Placebo (for sunitinib)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 21, 2016)
44
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2012)
104
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with midgut well-differentiated Grade 1-2 endocrine tumor.
  2. 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.
  3. 5HIAA levels superior to 1.5ULN as measured in each individual centre.
  4. Disease that is not amenable to surgery with curative intent.
  5. Presence of at least one measurable target lesion for further evaluation according to RECIST v1.1
  6. Adequate organ function
  7. ECOG Performance status 0 or 1.
  8. Life expectancy superior or equal to 3 months.
  9. Age superior or equal to 18 years.
  10. 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.
  11. Able to swallow oral compound.
  12. Signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial prior to enrollment.
  13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  14. Registration in a national health care system (CMU included).

Exclusion Criteria:

  1. Patients with undifferentiated, poorly differentiated gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, bronchial carcinoid tumors.
  2. Patients with carcinoid tumors with the presence of an obstructive intestinal tumor.
  3. Patients with uncontrolled cardiac complication as part of their carcinoid syndrome.
  4. Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent
  5. Current treatment with dose superior or equal to 120 mg per month of lanreotide
  6. 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.
  7. Patients who stopped everolimus treatment was less than 4 weeks prior to randomization.
  8. Patients with concomitant treatment with interferon.
  9. 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.
  10. 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.
  11. Treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days, respectively prior to study drug administration.
  12. Concomitant treatment with therapeutic doses of anticoagulants
  13. Concomitant treatment with a drug having proarrhythmic potential
  14. Unstable systemic diseases including uncontrolled hypertension or active uncontrolled infections.
  15. Current treatment on another clinical trial.
  16. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
  17. Ongoing cardiac dysrhythmias of NCI CTC grade superior or equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to more than 450 msec for males or more than 470 msec for females.
  18. Symptomatic brain metastases, spinal cord compression, or new evidence of brain or leptomeningeal disease.
  19. Left ventricular ejection fraction inferior or equal 50% as measured by either multigated acquisition scan or echocardiogram.
  20. Positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
  21. Patients with complicated, untreated lithiasis of the bile ducts
  22. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01731925
Other Study ID Numbers  ICMJE SUNLAND D12-01
2012-001098-94 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GERCOR - Multidisciplinary Oncology Cooperative Group
Study Sponsor  ICMJE GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators  ICMJE
  • Pfizer
  • Ipsen
Investigators  ICMJE
Principal Investigator: Pascal HAMMEL, MD Hôpital Beaujon
PRS Account GERCOR - Multidisciplinary Oncology Cooperative Group
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP