Islet Cell CarcinomaPhase 2NCT00363051
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
A Phase 2 study testing Everolimus 10 mg and Octreotide Depot in people with Islet Cell Carcinoma and Neuroendocrine Carcinoma, run by Novartis Pharmaceuticals at 54 sites in 11 countries.
Trial summary
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Islet Cell Carcinoma, Neuroendocrine Carcinoma, Neuroendocrine Tumor
- What is being tested?
- Everolimus 10 mg and Octreotide Depot
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 54 sitesin 11 countries
- Study dates
- Jun 2006to Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET)
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Objective disease progression by Response Evaluation Criteria in Solid tumors (RECIST) criteria while receiving cytotoxic chemotherapy or at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen)
- Presence of at least one measurable disease using RECIST criteria at screening (computer tomography [CT] or Magnetic resonance imaging [MRI])
- Adequate bone marrow, liver and kidney function
- WHO Performance Status 0-2.
Show all 9Show fewer
- Meet all inclusion criteria defined above for both strata.
- Receiving treatment (at least 3 consecutive months) with Octreotide Depot.
- In addition to documentation of progressive disease on or after chemotherapy, patients in stratum 2 must have documented objective progression of disease while receiving Octreotide Depot.
Who cannot join
- Anticancer therapy within 3 weeks of enrollment.
- Patients with poorly differentiated neuroendocrine carcinoma
- Hepatic artery embolization within the last 6 months
- Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus)
- Other concurrent malignancy
- Other serious intercurrent infections or nonmalignant uncontrolled medical illnesses
- Received treatment with Octreotide Depot or any other long-acting somatostatin analogue in the 60 days prior to enrollment or any short-acting somatostatin analogue in the two weeks prior to enrollment.
- Other protocol-defined inclusion/exclusion criteria applied.
Trial locations and contacts
54 sites in 11 countries.
54 sites in 11 countries
United States20 sites
Emory University Hospital
Atlanta, Georgia, 30322
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Arthur G. James Cancer Hospital/Ohio State University
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
M. D Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC Medical Center
Los Angeles, California, 90033
Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.
Los Angeles, California, 90048
UCLA Medical Center
Los Angeles, California, 90073
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
LSUHC Multispecialty Clinic
New Orleans, Louisiana, 70115
Lynn Ratner, M.D.
New York, New York, 10028
Oregon Health and Science University
Portland, Oregon, 97239-3098
Mayo Clinic
Rochester, Minnesota, 55905
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
H. Lee Moffit Cancer Center & Research Institute
Tampa, Florida, 33612
Scott & White Memorial Hospital
Temple, Texas, 76508
Germany7 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Erlangen
Novartis Investigative Site
Essen
Novartis Investigative Site
Frankfurt
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Marburg
Novartis Investigative Site
Ulm
France6 sites
Novartis Investigative Site
Billancourt, 92100
Novartis Investigative Site
Clichy, 92118
Novartis Investigative Site
Lyon, 03
Novartis Investigative Site
Reims
Novartis Investigative Site
Toulouse
Novartis Investigative Site
Villejuif
Canada5 sites
Novartis Investigative Site
Halifax, Nova Scotia, B34 2Y9
Novartis Investigative Site
London, Ontario, N6A 4L6
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E6
Italy5 sites
Novartis Investigative Site
Milan, 20141
Novartis Investigative Site
Modena
Novartis Investigative Site
Pisa, 56126
Novartis Investigative Site
Rome, 00189
Novartis Investigative Site
Torrette Di Ancona, 60020
Australia3 sites
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Herston
Novartis Investigative Site
Kogarah
Spain3 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
L'Hospitalet de Llobregat
Novartis Investigative Site
Madrid, 28040
Argentina2 sites
Novartis Investigative Site
Buenos Aires
Novartis Investigative Site
Santa Fe
About this study
Official title: An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.
Read the detailed description
This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy.
Stratum 1, consisted of patients not receiving chronic Octreotide Depot therapy, will receive everolimus monotherapy at 10 mg/day.
Stratum 2, consisting of patients with tumors that have progressed during Octreotide Depot treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mg/day.
- Conditions
- Islet Cell Carcinoma, Neuroendocrine Carcinoma, Neuroendocrine Tumor, Pancreatic Neoplasms
- Being tested
- Everolimus 10 mg, Octreotide Depot
- Keywords
- Pancreatic, Tumor, Islet Cell, Carcinoma, Neuroendocrine, Endocrine, Atypical Carcinoid, RADIANT1, RADIANT-1
- Medical subject headings
- Carcinoma, Islet Cell, Carcinoma, Neuroendocrine, Neuroendocrine Tumors, Pancreatic Neoplasms, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus 10 mgDrug
Also called RAD001
Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced.
Octreotide DepotDrug
| Study group | Role | What they receive |
|---|---|---|
| Everolimus 10 mg | Experimental | Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day.
Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy.
Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. Receives: Drug: Everolimus 10 mg; Drug: Octreotide Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
Measured: from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)
Secondary outcomes (11)
Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):
- 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 = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions
Measured: from date of first documented confirmed response to time to progression, at least 3 months
Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):
- 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 = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions
Measured: from date of first documented confirmed response to time to progression, at least 3 months
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
Measured: from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]
Adverse events 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. Serious adverse events 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.
Measured: on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]
Adverse events 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. Serious adverse events 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.
Measured: on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)
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 Kaplan-Meier estimate of the PFS survival function was constructed.
Median PFS was obtained and displayed along with 95% confidence intervals.
Measured: from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)
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 Kaplan-Meier estimate of the PFS survival function was constructed.
Median PFS was obtained and displayed along with 95% confidence intervals.
Measured: from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010
Time to Overall Survival (OS)(Stratum 1)
Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.
If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.
Measured: from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012
Time to Overall Survival (OS) (Stratum 2)
Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.
If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.
Measured: from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012
Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)
For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.
Measured: Cycle 1 Day 15
Effect of Octreotide Depot on the Trough Concentrations of Everolimus
The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.
Measured: Cycle 1 Day 1, Cycle 2 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2008
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Islet Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363051
- Sponsor's protocol ID
- CRAD001C2239
- Status last verified
- May 2013
- First submitted
- 2 Aug 2006
- Last updated
- 10 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT00363051
- Acronym / sponsor ID
- CRAD001C2239
- Conditions
- Islet Cell Carcinoma, Neuroendocrine Carcinoma, Neuroendocrine Tumor, Pancreatic Neoplasms
- Keywords
- Pancreatic, Tumor, Islet Cell, Carcinoma, Neuroendocrine, Endocrine, Atypical Carcinoid, RADIANT1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 30 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.
Detailed description
This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy.
Stratum 1, consisted of patients not receiving chronic Octreotide Depot therapy, will receive everolimus monotherapy at 10 mg/day.
Stratum 2, consisting of patients with tumors that have progressed during Octreotide Depot treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus 10 mg | Experimental | Drug: Everolimus 10 mg, Drug: Octreotide DepotStratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET)
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Objective disease progression by Response Evaluation Criteria in Solid tumors (RECIST) criteria while receiving cytotoxic chemotherapy or at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen)
- Presence of at least one measurable disease using RECIST criteria at screening (computer tomography [CT] or Magnetic resonance imaging [MRI])
- Adequate bone marrow, liver and kidney function
Key exclusion criteria (8 listed)
- Anticancer therapy within 3 weeks of enrollment.
- Patients with poorly differentiated neuroendocrine carcinoma
- Hepatic artery embolization within the last 6 months
- Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus)
- Other concurrent malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus 10 mgAlso: RAD001Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced. | Drug | Everolimus 10 mg |
| Octreotide Depot | Drug | Everolimus 10 mg |
Primary outcome
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)
Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
11 secondary outcomes
Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Time frame: from date of first documented confirmed response to time to progression, at least 3 months
Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Time frame: from date of first documented confirmed response to time to progression, at least 3 months
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]
Time frame: on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]
Time frame: on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)
Time frame: from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)
Time frame: from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010
Time to Overall Survival (OS)(Stratum 1)
Time frame: from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012
Time to Overall Survival (OS) (Stratum 2)
Time frame: from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012
Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)
Time frame: Cycle 1 Day 15
Effect of Octreotide Depot on the Trough Concentrations of Everolimus
Time frame: Cycle 1 Day 1, Cycle 2 Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
54 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus 10 mg and Octreotide Depot in people with Islet Cell Carcinoma and Neuroendocrine Carcinoma, run by Novartis Pharmaceuticals at 54 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Germany, France, Canada, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.