A Study to Assess the Safety and the Efficacy of the Combination of TH-302 and Sunitinib in Neuroendocrine Pancreatic Tumours
|ClinicalTrials.gov Identifier: NCT02402062|
Recruitment Status : Active, not recruiting
First Posted : March 30, 2015
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Pancreatic Neoplasms||Drug: TH-302 + Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||May 11, 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: TH-302 + Sunitinib
TH-302 + Sunitinib. Single arm Study.
Drug: 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.
Other Name: TH-302 + Sutent
- Objective response rate [ Time Frame: 48 months ]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 analysed population.
- Progression Free Survival (PFS) [ Time Frame: 48 months ]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.
- Time to Tumour Progression (TTP) [ Time Frame: 48 months ]It is defined as the time between the start of study treatment to date of the first objective evidence of radiological progression.
- Duration of Response (DR) [ Time Frame: 48 months ]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).
- Overall Survival (OR) [ Time Frame: 48 months ]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 (adverse events) [ Time Frame: time between the date of signing the informed consent until 28 days after the last dose of study drug ]Safety will be assessed according to the reports of adverse events, the frequency of treatment discontinuations due to adverse events, laboratory evaluations or ECG
- Biomarkers in serum and tumor tissue [ Time Frame: 48 months ]Assess the predictive/prognostic value of the analysed biomarkers in plasm and tumour.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402062
|Institut Catalá d'Oncologia L'Hospitalet|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Hospital Universitario Marqués de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Hospital Provincial de Castellón|
|Castelló, Valencia, Spain|
|Hospital Universitari Vall d'Hebron|
|Barcelona, Spain, 08035|
|Hospital Universitario Virgen de las Nieves|
|Granada, Spain, 18014|
|Hospital Universitario Ramón y Cajal|
|Madrid, Spain, 28034|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital Universitario Virgen de la Victoria|
|Málaga, Spain, 29010|
|Hospital Universitario Virgen del Rocío|
|Sevilla, Spain, 41013|
|Study Chair:||Enrique Grande, MD||Grupo Espanol de Tumores Neuroendocrinos|