Neuroendocrine TumorPhase 1NCT00804336
Pasireotide in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors
A Phase 1 study testing SOM230 and RAD001 in people with Neuroendocrine Tumor and Carcinoid Tumor, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this research study is to determine the safety of the combination of SOM230 and RAD001, as well as determine the highest dose of this combination that can be given to people safely. SOM230 is an investigational drug that is similar to Sandostatin LAR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumor, Carcinoid Tumor, Pancreatic Neuroendocrine Tumor
- What is being tested?
- SOM230 and RAD001
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2008to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Locally unresectable or metastatic neuroendocrine tumor. Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, and small cell carcinoma are not eligible.
- 18 years of age or older
- Minimum of four weeks since any major surgery, completion of radiation, of completion of all prior systemic anticancer therapy.
- ECOG Performance Status 0,1, or 2.
- Life expectancy 12 weeks or more.
- Adequate bone marrow, liver and renal function as outlined in the protocol
- Negative serum pregnancy test for women of childbearing potential.
- Fasting serum cholesterol less than or equal to 300mg/dL or less than or equal to 7.75mml/L AND fasting triglycerides of less than or equal to 2.5 x ULN.
Who cannot join
- Chronic treatment with systemic steroids or another immunosuppressive agent.
- Immunization with attenuated live vaccines during study or within 1 week of study entry.
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
- Prior or concurrent malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years.
- Uncontrolled diabetes mellitus or a fasting plasma glucose of > 1.5 ULN.
- Symptomatic cholelithiasis
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- Congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment.
- Presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result.
- Any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study such as: severely impaired lung function; active or uncontrolled infection/disorders; nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by treatment with the study therapy; impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001; history of alcohol or drug abuse in the 6 month period prior to receiving treatment.
- Known hypersensitivity to RAD001 or other rapamycins or its excipients.
- Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations.
- History of non-compliance to medical regimens.
- Patients taking medication known to inhibit, induce, or be a substrate to isoenzyme CYP3A.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02214
About this study
Official title: Phase I Study of Pasireotide (SOM230) in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors
The purpose of this research study is to determine the safety of the combination of SOM230 and RAD001, as well as determine the highest dose of this combination that can be given to people safely. SOM230 is an investigational drug that is similar to Sandostatin LAR. Sandostatin is an approved drug for the use of treating symptoms of neuroendocrine tumors. SOM230 has shown to be effective in patients who have become resistant to Sandostatin and may also stop cancer cells from growing. RAD001 is an investigational drug that also may stop cancer cells from growing.
Read the detailed description
- Participants will be receiving two study medications, SOM230 and RAD001, during each treatment cycle. Each treatment cycle lasts 4 weeks.
- For the first four weeks of treatment, the participant will self-administer the SOM230 twice a day by subcutaneous injection. If they tolerate the SOM230 after 4 weeks, they will switched to the long-acting SOM230 which will be administered during scheduled treatment visits once every 4 weeks. For the first two weeks after switching to the long-acting SOM230, participants will continue to self-administer the short-acting SOM230 twice a day.
- RAD001 will be taken orally once every day.
- On Day 1 of every cycle, a physical exam and blood tests will be performed. Following every 2 cycles of treatment an assessment of the tumor by CT scan wil be performed.
- Pharmacokinetic (pK) blood samples will be taken on days 1 and 15 of cycle one. The pK samples will be taken right before the study drug is administered and then 1, 2, 3, and 5 hours later.
- Being tested
- SOM230, RAD001
- Keywords
- pasireotide, SOM230, RAD001
- Medical subject headings
- Neuroendocrine Tumors, Carcinoid Tumor, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOM230Drug
Also called pasireotide
Given subcutaneously twice a day for four weeks then given intramuscularly once every four weeks thereafter
RAD001Drug
Given orally once a day
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide and RAD001 | Experimental | RAD001 was administered orally as a once-daily dose. Pasireotide s.c. was self-administered s.c. twice daily for 4 weeks. If pasireotide s.c. was tolerated, patients received pasireotide LAR i.m. at the corresponding dose level. Pasireotide s.c. was continued for an additional 2 weeks after administration of pasireotide LAR until anticipated steady-state levels of pasireotide LAR were achieved. Pasireotide LAR was administered every 28 days. Cycles for everolimus and pasireotide LAR were repeated every 28 days. Receives: Drug: SOM230; Drug: RAD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose for pasireotide (SOM230) in combination with RAD001 in this patient population.
Measured: 2 years
To determine the dose-limiting toxicities of the combination in this patient population.
Measured: 2 years
Secondary outcomes (5)
To determine the pharmacokinetics of combined treatment
Measured: 2 years
To make a preliminary assessment of the anti-tumor activity of the combination in this patient population
Measured: 2 years
To determine the objective response rate
Measured: 3 years
To determine the duration of response
Measured: 3 years
To determine the progression free survival and overall survival of patients receiving this combination.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, Novartis
- Responsible party
- Principal investigator, Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Jennifer Ang Chan, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804336
- Sponsor's protocol ID
- 08-087
- Status last verified
- Oct 2016
- First submitted
- 5 Dec 2008
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan JA, Ryan DP, Zhu AX, Abrams TA, Wolpin BM, Malinowski P, Regan EM, Fuchs CS, Kulke MH. Phase I study of pasireotide (SOM 230) and everolimus (RAD001) in advanced neuroendocrine tumors. Endocr Relat Cancer. 2012 Sep 14;19(5):615-23. doi: 10.1530/ERC-11-0382. Print 2012 Oct.
PubMed 22736724
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Pasireotide (SOM230) in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00804336
- Acronym / sponsor ID
- 08-087
- Keywords
- pasireotide, SOM230, RAD001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, Novartis
- Study start
- Oct 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Dec 2008 (estimated)
- Results
- Not posted in the source record
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 research study is to determine the safety of the combination of SOM230 and RAD001, as well as determine the highest dose of this combination that can be given to people safely. SOM230 is an investigational drug that is similar to Sandostatin LAR. Sandostatin is an approved drug for the use of treating symptoms of neuroendocrine tumors. SOM230 has shown to be effective in patients who have become resistant to Sandostatin and may also stop cancer cells from growing. RAD001 is an investigational drug that also may stop cancer cells from growing.
Detailed description
- Participants will be receiving two study medications, SOM230 and RAD001, during each treatment cycle. Each treatment cycle lasts 4 weeks.
- For the first four weeks of treatment, the participant will self-administer the SOM230 twice a day by subcutaneous injection. If they tolerate the SOM230 after 4 weeks, they will switched to the long-acting SOM230 which will be administered during scheduled treatment visits once every 4 weeks. For the first two weeks after switching to the long-acting SOM230, participants will continue to self-administer the short-acting SOM230 twice a day.
- RAD001 will be taken orally once every day.
- On Day 1 of every cycle, a physical exam and blood tests will be performed. Following every 2 cycles of treatment an assessment of the tumor by CT scan wil be performed.
- Pharmacokinetic (pK) blood samples will be taken on days 1 and 15 of cycle one. The pK samples will be taken right before the study drug is administered and then 1, 2, 3, and 5 hours later.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pasireotide and RAD001 | Experimental | Drug: SOM230, Drug: RAD001RAD001 was administered orally as a once-daily dose. Pasireotide s.c. was self-administered s.c. twice daily for 4 weeks. If pasireotide s.c. was tolerated, patients received pasireotide LAR i.m. at the corresponding dose level. Pasireotide s.c. was continued for an additional 2 weeks after administration of pasireotide LAR until anticipated steady-state levels of pasireotide LAR were achieved. Pasireotide LAR was administered every 28 days. Cycles for everolimus and pasireotide LAR were repeated every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Locally unresectable or metastatic neuroendocrine tumor. Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, and small cell carcinoma are not eligible.
- 18 years of age or older
- Minimum of four weeks since any major surgery, completion of radiation, of completion of all prior systemic anticancer therapy.
- ECOG Performance Status 0,1, or 2.
- Life expectancy 12 weeks or more.
Key exclusion criteria (13 listed)
- Chronic treatment with systemic steroids or another immunosuppressive agent.
- Immunization with attenuated live vaccines during study or within 1 week of study entry.
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
- Prior or concurrent malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years.
- Uncontrolled diabetes mellitus or a fasting plasma glucose of > 1.5 ULN.
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 |
|---|---|---|
| SOM230Also: pasireotideGiven subcutaneously twice a day for four weeks then given intramuscularly once every four weeks thereafter | Drug | Pasireotide and RAD001 |
| RAD001Given orally once a day | Drug | Pasireotide and RAD001 |
Primary outcome
To determine the maximum tolerated dose for pasireotide (SOM230) in combination with RAD001 in this patient population.
Time frame: 2 years
To determine the dose-limiting toxicities of the combination in this patient population.
Time frame: 2 years
5 secondary outcomes
To determine the pharmacokinetics of combined treatment
Time frame: 2 years
To make a preliminary assessment of the anti-tumor activity of the combination in this patient population
Time frame: 2 years
To determine the objective response rate
Time frame: 3 years
To determine the duration of response
Time frame: 3 years
To determine the progression free survival and overall survival of patients receiving this combination.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Results publication: PubMed 22736724Chan JA, Ryan DP, Zhu AX, Abrams TA, Wolpin BM, Malinowski P, Regan EM, Fuchs CS, Kulke MH. Phase I study of pasireotide (SOM 230) and everolimus (RAD001) in advanced neuroendocrine tumors. Endocr Relat Cancer. 2012 Sep 14;19(5):615-23. doi: 10.1530/ERC-11-0382. Print 2012 Oct.
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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.
Jennifer Ang Chan, MD, MPH principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOM230 and RAD001 in people with Neuroendocrine Tumor and Carcinoid Tumor, run by Dana-Farber Cancer Institute at 3 sites in United States.
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 8 inclusion and 13 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximum tolerated dose for pasireotide (SOM230) in combination with RAD001 in this patient population. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804336, which also lists 1 linked publication.
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 19 Oct 2016.