Overview

This trial is active, not recruiting.

Condition advanced neuroendocrine tumors
Treatments everolimus, placebo to everolimus
Phase phase 3
Targets mTOR, FKBP-12
Sponsor Novartis Pharmaceuticals
Start date July 2007
End date February 2010
Trial size 410 participants
Trial identifier NCT00510068, 2006-006819-75, CRAD001C2324

Summary

The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants received 10 mg per day of Everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
everolimus RAD001
A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets.
(Placebo Comparator)
Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
placebo to everolimus
a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.

Primary Outcomes

Measure
Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology
time frame: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010

Secondary Outcomes

Measure
Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})
time frame: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)
time frame: on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation
Time to Overall Survival
time frame: Baseline, to death- no time limit
Evaluation of Pharmacokinetics (PK) Parameters
time frame: Day 1 of every cycle (28 days/cycle) throughout the study
Changes From Baseline in Serum Biochemical Tumor Markers, Such as Chromogranin A (CgA) and Neuron Specific Enolase (NSE)
time frame: If elevated at baseline, evaluated every cycle visit (28 days/cycle)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: 1. Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET 2. Measurable disease by radiologic assessment 3. Adequate blood work 4. Performance Status 0-2 : Ability to be out of bed most of the time 5. Adult male or female patients ≥ 18 years of age 6. Women of childbearing potential must have a negative serum pregnancy test 7. Written informed consent from patients must be obtained in accordance to local guidelines Exclusion criteria: 1. Patients with severe kind of (poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma) cancer are not eligible 2. Other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting this trial 3. Hepatic artery procedure called embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment 4. Prior therapy with the same kind of medication (mTOR inhibitors: sirolimus, temsirolimus, everolimus). 5. Uncontrolled diabetes mellitus Patients who have any severe and/or uncontrolled medical conditions such as: 6. Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent 7. Patients with a known history of HIV seropositivity 8. No other prior or concurrent cancer at the time enrolling to this trial Other protocol defined inclusion/ exclusion criteria applied

Additional Information

Official title A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Novartis.