Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01731925
Other study ID # SUNLAND D12-01
Secondary ID 2012-001098-94
Status Active, not recruiting
Phase Phase 2
First received November 19, 2012
Last updated January 30, 2017
Start date January 7, 2013
Est. completion date December 2017

Study information

Verified date January 2017
Source Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

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.
Placebo (for sunitinib)

Sunitinib
Sunitinib 37.5 mg daily

See more »

Sponsors (3)

Lead Sponsor Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) Ipsen, Pfizer

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall survival (OS) To evaluate overall survival (OS) in sunitinib- and placebo-treated subjects. time from date of randomization to date of death, assessed up to 3 years after the beginning of the study
Secondary Objective response (OR) To evaluate objective response (OR) rate in sunitinib- and placebo-treated subjects. from randomization until disease progression, assessed up to 3 years after the beginning of the study
Secondary Duration of response (DR) To evaluate duration of response (DR) in sunitinib- and placebo-treated subjects in subjects achieving a response. 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
Secondary Time to tumor response (TTR) To assess time to tumor response (TTR) for sunitinib- and placebo-treated subjects. 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
Secondary Biological responses To evaluate the best biological responses as assessed using serum chromogranin A and urine 5HIAA for sunitinib- and placebo-treated subjects. from baseline to end of treatment, assessed up to 3 years after the beginning of the study
Secondary Safety To assess safety and tolerability of sunitinib in the study population. from visit 1 to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study
Secondary Quality of life To assess Health related Quality of life (EORTC QLQ C-30). From screening to 1 month after last study drug administration, assessed up to 3 years after the beginning of the study
See also
  Status Clinical Trial Phase
Completed NCT02441062 - Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors Phase 2
Completed NCT00580320 - Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma Phase 1
Completed NCT02575300 - Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors Phase 2
Active, not recruiting NCT02441088 - Theranostics: 68GaDOTATOC and 90YDOTATOC Phase 2
Terminated NCT00227136 - Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion Phase 3
Terminated NCT00947167 - A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors Phase 2
Terminated NCT02177773 - GA-68 DOTA-TOC of Somatostatin Positive Malignancies Phase 1/Phase 2
Active, not recruiting NCT02795858 - A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors Phase 2
Terminated NCT02859064 - Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres Phase 2
Completed NCT00088595 - Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors Phase 2
Completed NCT01619865 - Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors Phase 1/Phase 2
Completed NCT01253161 - Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs) Phase 2
Terminated NCT02359500 - 68Ga-Dotatoc Positron Emission Tomography (PET) for Somatostatin Receptor-Positive Neuroendocrine Tumors (NETs) Phase 1
Not yet recruiting NCT01373736 - 123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors Phase 3
No longer available NCT01980732 - 68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors N/A