Neuroendocrine TumorsPhase 1NCT01364415
Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
A Phase 1 study testing Pasireotide LAR in people with Neuroendocrine Tumors, run by Novartis Pharmaceuticals at 4 sites in United States.
Trial summary
This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Pasireotide LAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2011to Apr 2016
- 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
- ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
- unresectable metastatic NET tumor with measurable disease
- life expectancy ≥ 12 weeks
Who cannot join
- Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
- patients with known hypersensitivity to somatostatin analogs
- patients with symptomatic cholelithiasis in the past 2 months
- patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
- patients with known history of hepatitis C or chronic active hepatitis B
- patients with diagnosis of HIV.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana Farber Cancer Institute SC-6
Boston, Massachusetts, 02215
University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr
Houston, Texas, 77030-4009
Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, California, 90048
H. Lee Moffitt Cancer Center & Research Institute SC-1
Tampa, Florida, 33612
About this study
Official title: A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)
This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Pasireotide LAR
- Keywords
- MTD, pasireotide, LAR, NETs, advanced neuroendocrine tumors
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide LARDrug
Also called SOM230
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide LAR | Experimental | Not described Receives: Drug: Pasireotide LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs
Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.
Measured: Sequentiona 56 day cohorts until the MTD is determined
Secondary outcomes (4)
assess the safety and tolerability of pasireotide LAR
Incidence of adverse drug events, overall and by severity and incidence of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, Holter monitor, imaging for gallstones, and assessment of physical examinations such as vital signs
Measured: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
assess the pharmacokinetics (PK) of pasireotide LAR
Pasireotide Cmax and Ctrough
Measured: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
assess the pharmacodynamics (PD) of pasireotide LAR
Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase
Measured: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR.
Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS).
Measured: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2016
- Study completionApr 2016
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 TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT01364415
- Sponsor's protocol ID
- CSOM230D2101
- Status last verified
- Jun 2016
- First submitted
- 18 May 2011
- Last updated
- 21 Dec 2020
- Results posted
- No
Publications
Yao JC, Chan JA, Mita AC, Kundu MG, Hermosillo Resendiz K, Hu K, Ravichandran S, Strosberg JR, Wolin EM. Phase I dose-escalation study of long-acting pasireotide in patients with neuroendocrine tumors. Onco Targets Ther. 2017 Jun 27;10:3177-3186. doi: 10.2147/OTT.S128547. eCollection 2017.
PubMed 28721067
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)
- ClinicalTrials.gov ID
- NCT01364415
- Acronym / sponsor ID
- CSOM230D2101
- Conditions
- Neuroendocrine Tumors
- Keywords
- MTD, pasireotide, LAR, NETs, advanced neuroendocrine tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Jun 2011 (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.
This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pasireotide LAR | Experimental | Drug: Pasireotide LAR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
- unresectable metastatic NET tumor with measurable disease
- life expectancy ≥ 12 weeks
Key exclusion criteria (7 listed)
- Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
- patients with known hypersensitivity to somatostatin analogs
- patients with symptomatic cholelithiasis in the past 2 months
- patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
- patients with known history of hepatitis C or chronic active hepatitis B
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 |
|---|---|---|
| Pasireotide LARAlso: SOM230 | Drug | Pasireotide LAR |
Primary outcome
Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs
Time frame: Sequentiona 56 day cohorts until the MTD is determined
Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.
4 secondary outcomes
assess the safety and tolerability of pasireotide LAR
Time frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
assess the pharmacokinetics (PK) of pasireotide LAR
Time frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
assess the pharmacodynamics (PD) of pasireotide LAR
Time frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR.
Time frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
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 21 Dec 2020.
- Derived from this study: PubMed 28721067Yao JC, Chan JA, Mita AC, Kundu MG, Hermosillo Resendiz K, Hu K, Ravichandran S, Strosberg JR, Wolin EM. Phase I dose-escalation study of long-acting pasireotide in patients with neuroendocrine tumors. Onco Targets Ther. 2017 Jun 27;10:3177-3186. doi: 10.2147/OTT.S128547. eCollection 2017.
- Results for CSOM230D2101 can be found on the Novartis Clinical Trial Results WebsiteLink 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
4 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 Pasireotide LAR in people with Neuroendocrine Tumors, run by Novartis Pharmaceuticals at 4 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 3 inclusion and 7 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs (time frame: Sequentiona 56 day cohorts until the MTD is determined). 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 NCT01364415, 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 21 Dec 2020.