Predictive Biomarkers of Response to Sunitinib in the Treatment of Poorly-differentiated NEURO-Endocrine Tumors

NCT01215578 | Terminated Phase 2 DMC

• 2 other identifiers: P0701452007-005628-34
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify predictive molecular markers of response to continuous daily sunitinib at dose of 37.5 mg used in patients with poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors. Hypothesis:

• To distinguish molecular markers based on their expression at the initial biopsy, their detection by proteomic analysis and demonstrating that tumor or vascular cells are straightaway sensitive to sunitinib (markers sensitivity).
• The presence of these markers at the initial biopsy predict the sensitivity to sunitinib(Positive predictive value of markers)

Conditions

Neuroendocrine Tumors; Pancreatic Neoplasms; Advanced Disease; Sunitinib

Keywords

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Adenoma, Islet Cell; Adenocarcinoma; Carcinoma; Adenoma; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Sunitinib; Antineoplastic Agents; Therapeutic Uses; Pharmacologic Actions; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors

Outcome Measures

Primary Outcomes (1)

• Predictive molecular markers of response to sunitinib

  to assess the correlation between the expression of biomarkers and CT scan response. Patients are considered as responders when objective response (Partial or complete response) is showed on CT scan.

  1 year

Secondary Outcomes (2)

• The antitumor activity of sunitinib

  1 year

• Residual concentration

  2 months

Study Arms (1)

patient treated

EXPERIMENTAL

patient who receive sunitinib (SUTENT)

Drug: Sutent

Interventions

Sutent DRUG

sunitinib 37.5 mg/day (per os) for 6 months

patient treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Digestive NET histopathologically proven, poorly-differentiated
• Inoperable/advanced NET (Tumor relapse inoperable or metastatic with no surgical indication).
• Tumor samples should be made available for analysis(diagnostic biopsy, surgical specimen)
• measurable disease defined by at least one lesion wich can be measured by at least one dimension :
• equal or superior to 20 mm ( by conventional methods )
• equal or superior to 10 mm (by spiral scan within 28 days before the beginning of the treatment)
• Performance status WHO ≤ 2.
• Adequate organ function :
• hematology (absolute neutrophil count equal or superior to 1,5 x 10\*9/l , platelet equal or superior to 100 x 10\*9/l),
• clearance of creatinine equal or superior to 60 ml/min),
• AST/ALT ≤ 5 N, PAL ≤ 5 N, total bilirubin ≤ 2N.
• the selected women must be post-menopausal woman or surgically castrated or have to accept an effective contraception for the duration of the treatment and 3 month after.Women who are old enough to procreate must have a negative pregnancy test within the 72 hours of the beginning of the treatment.They must not be pregnant or to breastfeed.the selected men and theirs partners must be sterile or use an effective contraception for the duration of the treatment and 3 month after.

You may not qualify if:

• Hypersensitivity to sunitinib.
• Contraindication to sunitinib, including uncontrolled hypertension, medical history of cerebrovascular accident, unstable cardiac pathology despite optimal medical therapy (myocardial infarction within the 6 months prior to study drug administration, severe/unstable angina ), active hemorrhagic syndrome or concomitant treatment with anticoagulants.
• Any severe acute or chronic co-morbid that may compromise to comply with study participation: uncontrolled infection, symptomatic congestive heart failure, liver disturbance, chronic renal failure, active gastro-duodenal ulcer (nonexhaustive list).
• Known brain metastases.
• Diagnosis of any second malignancy within the last 3 years, except for basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
• Current treatment on another clinical trial.
• Prior treatment with an investigational agent within 4 weeks.
• Prior treatment with intravenous biphosphonates

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Beaujon

Clichy, Hauts de Seine, 92110, France

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Pancreatic Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Adenoma, Islet Cell; Adenocarcinoma; Carcinoma; Adenoma; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

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

Study Officials

• Eric Raymond, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: October 6, 2010
• Study Start: October 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

FR (1)