Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Neuroendocrine Tumors

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Combination of the two drugs in cycles of 28 days, described as follows:

Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.

TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.

TH-302 + Sunitinib

Enrique Grande, MD

The purpose of this study is to determine the safety and the efficacy of the combination of the drugs TH-302 and sunitinib in metastatic neuroendocrine tumours.

The purpose of this study is to determine the safety and the efficacy of the combination of the drugs TH-302 and sunitinib in Treatment-naïve patients with well- and moderately-differentiated metastatic Pancreatic Neuroendocrine Tumours (pNET).

A Study to Assess the Safety and the Efficacy of the Combination of TH-302 and Sunitinib in Neuroendocrine Pancreatic Tumours

A Phase II Study to Assess the Activity and Safety of TH-302 in Combination With Sunitinib in Treatment-naïve Patients With Well- and Moderately-differentiated Metastatic Pancreatic Neuroendocrine Tumours (pNET)

Objective response rate: percentage of patients in whom a complete response (CR) or a partial response (PR) is confirmed according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in relation to the total of the analyzed population.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions

Time between the start of study treatment to date of the first objective evidence of radiological progression or patient death due to any cause; which comes first.

It is defined as the time between the start of study treatment to date of the first objective evidence of radiological progression.

It is defined as the time between the start from the first documentation of objective response (CR or PR) which is subsequently confirmed until the first objective evidence of radiological progression or death from any cause. DR is calculated only in the subgroup of patients with an objective response (CR + PR).

It is defined as the time between the start of study treatment to date of death from any cause. If it were impossible to obtain confirmation of the death, survival will be censored with the date of the last Visit that it is satisfied that the patient was alive.

Safety will be assessed according to the reports of adverse events, the frequency of treatment discontinuations due to adverse events, laboratory evaluations or ECG

Assess the predictive/prognostic value of the analysed biomarkers in plasm and tumour.

Threshold Pharmaceuticals

Pfizer

Grupo Espanol de Tumores Neuroendocrinos

TH-302 + Sunitinib. Single arm Study.

TH-302 + Sunitinib: Combination of the two drugs in cycles of 28 days, described as follows:

Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.

TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Spain

Region of Enrollment

The ECOG Performance Status is a simple measure of functional status. It has scores ranging from 0 to 5:

0: Fully active, without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
5. Death

ECOG PS

Electrocardiogram (ECG)

Left ventricular ejection fraction (LVEF) higher than 50%

Left ventricular ejection fraction (LVEF)

The Charlson comorbidity index predicts the one-year mortality for a patient who may have a range of comorbid conditions. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. The total scores range from 0 to 37.

Abbreviated Charlson comorbidity index

Peripheral arterial disease

Diabetes

grade I: cancer cells that resemble normal cells and aren't growing rapidly grade II: cancer cells that don't look like normal cells and are growing faster than normal cells grade III: cancer cells that look abnormal and may grow or spread more aggressively

Tumor histological grade

KI-67 is a measure of the rate of tumor growth, the higher the rate of Ki-67 proliferation, the faster cells are dividing, and is another prognostic factor.

Ki-67 index

The mitotic index is the number of cells undergoing mitosis divided by the total number of cells noted per 10 high power fields.

Mitosis 10 HPF

Primary tumor surgery

stage 0: indicates that the cancer is where it started (in situ) and hasn't spread stage I: the cancer is small and hasn't spread anywhere else stage II: the cancer has grown, but hasn't spread stage III: the cancer is larger and may have spread to the surrounding tissues and/or the lymph nodes (part of the lymphatic system) stage IV: the cancer has spread from where it started to at least one other body organ; also known as "secondary" or "metastatic" cancer

Tumor stage at diagnosis

Tumor relapse location

Somatostanine analogues prior the trial

Baseline concomitant medication

Weight

Height

Body mass index (BMI)

Body surface area (BSA)

Blood pressure systolic (BPs)

Blood pressure diastolic (BPd)

Haemoglobin

White blood cells

Absolute neutrophil count

Absolute Lymphocytes count

Platelet count

Sodium blood levels

Potassium blood levels

Calcium blood levels

Magnesium blood levels

Glucose

Creatinine

Aspartate AST (SGOT)

Alanine transaminase ALT (SGPT)

AST (SGOT)/ ALT (SGPT) (baseline)

Total bilirubin

Gamma-glutamyltransferase (GGT)

Alkaline phosphatase (AP)

Albumin

Lactate dehydrogenase (LDH)

CG a tumor marker

Enolase 1

Time between diagnosis (anatomical pathology) and treatment initiation in months

Spots Global Cancer Trial Database for A Study to Assess the Safety and the Efficacy of the Combination of TH-302 and Sunitinib in Neuroendocrine Pancreatic Tumours

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial