Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Adenoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Carcinoma, Pancreatic Ductal

Endocrine Gland Neoplasms

Adenoma, Islet Cell

Pancreatic Diseases

Digestive System Neoplasms

Carcinoma, Islet Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Gastrointestinal Agents

Vitamins

Gemcitabine

Paclitaxel

Irinotecan

Leucovorin

Fluorouracil

Levoleucovorin

Albumin-Bound Paclitaxel

Oxaliplatin

Folic Acid

Folfirinox

Pancrelipase

Pancreatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Administered continuously twice daily with doses separated by 12 hours

BBI608

Nab-paclitaxel 125 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle

Nab-paclitaxel

Gemcitabine 1000 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle

Oxaliplatin 85 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

Arm C, D: Leucovorin 400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

Arm B: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

Arm B, D: Fluorouracil 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Fluorouracil 400 mg/m\^2 I.V. bolus followed by 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

MM-398 70 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

MM-398

This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin.

This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with either Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. Combination treatment will continue in 28 day cycles until disease progression, unacceptable toxicity or another discontinuation criterion is met. BBI608 may be continued post-progression if the patient is obtaining potential clinical benefit, in the opinion of the investigator. If administration of Gemcitabine and/or nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin is discontinued due to chemotherapy backbone-related toxicities, the administration of BBI608 can be continued.

A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer

A Phase Ib Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Metastatic Pancreatic Adenocarcinoma

Assess the preliminary anti-tumor activity of BBI608 when administered in combination with standard chemotherapies in adult patients with metastatic pancreatic adenocarcinoma by performing serum carbohydrate antigen 19-9 (CA 19-9) level measurement every 4 weeks

Blood sampling to assess the pharmacokinetic profile (Area under the curve) of BBI608.

Tumor Biopsy to provide information of the biomarkers by histopathology and Cancer Stem Cell assays.

Sumitomo Pharma America, Inc.

Gastrointestinal Diseases

Neuroendocrine Tumors

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Endocrine System Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neuroendocrine Tumor

Neuroepithelioma

Angiogenesis Inhibitors

Sunitinib

Growth Inhibitors

Protein Kinase Inhibitors

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

Sutent

Eric Raymond, Professor

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)

Neuroendocrine tumors (NET) are rare malignancies (1-2% of digestive cancers); and there is, in recent years, a slow but steady increase in their incidence. Despite the joint efforts of several research groups, which led to the new WHO classification (2002), the natural history of the disease remains heterogene and the resistance to conventional cytotoxic treatment remains the common denominator of these tumors.

Indeed, the prognosis of patients with metastatic disease remains poor despite numerous treatments (including: IFN, DTIC, 5-FU, doxorubicin, somatostatin analogues, etc.).

None of which showed a benefit in terms of survival. The main therapeutic objective is still to get a palliative effect on the symptoms and / or limit a few months tumor progression.

There are many publications showing that angiogenesis is one of the major mechanisms of tumor progression in TNE. But the multiple signaling pathways involved, the existence of alternative routes and their relationship to apoptosis inducing molecules remain unknown. Sunitinib is a new molecule in the family of tyrosine kinase inhibitors targeting multiple receptors which VEGFR, KIT, PDGF-R, FLT3 and RET. Since 2006 year, Sunitinib has been approved to treat advanced kidney cancer also called advanced renal cell carcinoma (a typically chemoresistant disease for which there was no active treatment available).

Many retrospective studies in patients showing that the TNE overexpress one or more targets of sunitinib. In Phase I trial, an antitumor activity has been identified in neuroendocrine tumors. In a phase II trial including 100 patients with well-differentiated TNE and carcinoids, sunitinib is associated with a response rate of 10%, and 82% of clinical benefit in the form of tumor stability.

Currently, an international randomised phase III trial initiated in well differentiated forms, but no studies are underway for poorly-differentiated TNE.

All of this suggests that sunitinib could represent an important therapeutic option for moderate, or poorly differentiated inoperable TNE and needs to be explored in this pathology by identifying predictive biomarkers of response.

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

A Multicenter Phase II Open Study Coupled With a Translational Assessment of Biomarkers Predictive of Response to Sunitinib in Patients With Poorly-differentiated Advanced/Inoperable NEURO-Endocrine Tumors.

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.

* Objective response according to RECIST criteria (Time Frame: duration of study Safety issue: No).
* Overall Survival (Time Frame: 6 months. Safety issue: No).
* Progression-free survival (PFS)
* Correlation between overall survival, PFS and tumor necrosis assessed on CT scan

correlation between the concentration of sunitinib and its major active metabolite, SU012662, and objective response and /or toxicity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer	NCT02231723	Metastatic Panc...	BBI608 Nab-paclitaxel Gemcitabine Oxaliplatin Leucovorin Irinotecan Fluorouracil MM-398	18 Years -	Sumitomo Pharma America, Inc.
Predictive Biomarkers of Response to Sunitinib in the Treatment of Poorly-differentiated NEURO-Endocrine Tumors	NCT01215578	Neuroendocrine ... Pancreatic Neop... Advanced Diseas... Sunitinib	Sutent	18 Years -	Assistance Publique - Hôpitaux de Paris

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