Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00412061

First received: December 13, 2006

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

Results First Received: October 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Carcinoid Tumor Malignant Carcinoid Syndrome
Interventions:	Drug: Everolimus Drug: Octreotide Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 429 patients were randomized to double blind phase of treatment.

Reporting Groups

Description

Octreotide+ Everolimus

Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.

Octreotide+ Placebo

Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.

Participant Flow: Overall Study

	Octreotide+ Everolimus	Octreotide+ Placebo
STARTED	216	213
Safety Population	215	211
COMPLETED	95 ^[1]	146
NOT COMPLETED	121	67
Ongoing, on study drug	37	34
Adverse Event	57	14
Withdrawn consent	17	11
Death	6	2
Protocol Violation	3	4
New cancer therapy	1	1
Lost to Follow-up	0	1

[1]	Patients listed as completed discontinued due to disease progression.

Baseline Characteristics

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Reporting Groups

	Description
Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
Octreotide+ Placebo	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
Total	Total of all reporting groups

Baseline Measures

	Octreotide+ Everolimus	Octreotide+ Placebo	Total
Number of Participants [units: participants]	216	213	429
Age [units: years] Mean ± Standard Deviation	60.1 ± 10.72	59.4 ± 11.13	59.8 ± 10.92
Gender [units: patients]
Female	119	89	208
Male	97	124	221

Outcome Measures

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1. Primary:

Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review [ 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, 10 January 2007, until cut-off date 02 April 2010 ]

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2. Secondary:

Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST) [ 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, 10 January 2007, until cut-off date 02 April 2010 ]

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3. Secondary:

Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) [ Time Frame: From first day of treatment up to 28 days after last day of treatment in double blind (safety data collected till data cut off date i.e. 2nd April 2010) ]

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4. Secondary:

Progression Free Survival (PFS) as Per Adjudicated Central Review by Change From Baseline Chromogranin A (CgA) and 5-hydroxyindoleacetic Acid (5-HIAA) [ Time Frame: If elevated at baseline, evaluated every cycle visit (28 days/cycle) ]

Results not yet posted. Anticipated Posting Date: 08/2013 Safety Issue: No

5. Secondary:

Overall Survival Using Kaplan-Meier Methodology [ Time Frame: The date of randomization to the date of death ]

Results not yet posted. Anticipated Posting Date: 08/2013 Safety Issue: No

6. Secondary:

Evaluation of Pharmacokinetics (PK)Parameters [ Time Frame: Day 1 of every cycle (28 days/cycle) throughout the study ]

Results not yet posted. Anticipated Posting Date: 08/2013 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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