Trial record 1 of 1 for:
crad001c2325
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor (RADIANT-2)
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| ClinicalTrials.gov Identifier: NCT00412061 |
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Recruitment Status :
Completed
First Posted : December 15, 2006
Results First Posted : March 12, 2012
Last Update Posted : November 21, 2014
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carcinoid Tumor Malignant Carcinoid Syndrome | Drug: Octreotide Drug: Placebo Drug: Everolimus | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 429 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo |
| Study Start Date : | December 2006 |
| Actual Primary Completion Date : | April 2010 |
| Actual Study Completion Date : | June 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Carcinoid Tumors
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: Octreotide
Octreotide 30 mg intramuscularly (i.m.) every 28 days.
Other Name: Sandostatin LAR® Depot Drug: Everolimus A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.
Other Name: RAD001 |
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Placebo Comparator: 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.
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Drug: Octreotide
Octreotide 30 mg intramuscularly (i.m.) every 28 days.
Other Name: Sandostatin LAR® Depot Drug: Placebo A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo. |
Primary Outcome Measures :
- 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 ]Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.
Secondary Outcome Measures :
- 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 ]The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.
- Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level [ Time Frame: If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 ]5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.
- Overall Survival Using Kaplan-Meier Methodology [ Time Frame: Months 12, 24, 36, 48 ]Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.
- Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase) [ Time Frame: From first day of treatment up to 28 days after last day of treatment in double blind ]AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
- Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase) [ Time Frame: From first day of treatment up to 28 days after last day of treatment in double blind ]AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
- Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA) [ Time Frame: If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010 ]Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as "Non-elevated".
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Advanced (unresectable or metastatic) carcinoid tumor
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Documented progression of disease within 12 months prior to randomization.
- Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).
Exclusion criteria:
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
- Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)
- Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
- Severe or uncontrolled medical conditions
- Chronic treatment with corticosteroids or other immunosuppressive agent.
- Other primary cancer within 3 years.
Other protocol-defined inclusion/exclusion criteria applied
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412061
Locations
Show 70 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00412061 |
| Other Study ID Numbers: |
CRAD001C2325 2006-004507-18 ( EudraCT Number ) |
| First Posted: | December 15, 2006 Key Record Dates |
| Results First Posted: | March 12, 2012 |
| Last Update Posted: | November 21, 2014 |
| Last Verified: | November 2014 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Cancer Carcinoid Tumor Neuroendocrine |
Carcinoma Everolimus Octreotide |
Additional relevant MeSH terms:
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Carcinoid Tumor Malignant Carcinoid Syndrome Serotonin Syndrome Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Drug-Related Side Effects and Adverse Reactions |
Chemically-Induced Disorders Everolimus Octreotide MTOR Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Gastrointestinal Agents Antineoplastic Agents, Hormonal |