Lung Neuroendocrine NeoplasmPhase 1\MACS1304NCT01324492
Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
A Phase 1 study testing RAD001 in people with Lung Neuroendocrine Neoplasm, run by Novartis Pharmaceuticals at 4 sites in China.
Trial summary
The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Neuroendocrine Neoplasm
- What is being tested?
- RAD001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2010to Jun 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed carcinoid tumors
- Newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible
Who cannot join
- Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis(non-clinical symptoms with brain lesions is eligible)
- Received Cytotoxic chemotherapy, immunotherapy or radiotherapy prior to enrollment
- Patients with a concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer
- Prior therapy with RAD001 or other mTOR inhibitors (sirolimus, temsirolimus, everolimus)
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Changchun, Jilin
Novartis Investigative Site
Guangzhou, Guangdong, 510030
Novartis Investigative Site
Shenyang, Liaoning
About this study
Official title: A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.
- Conditions
- Lung Neuroendocrine Neoplasm
- Being tested
- RAD001
- Keywords
- phase Ib,, RAD001,, advanced pulmonary neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
Also called Everolimus
| Study group | Role | What they receive |
|---|---|---|
| RAD001 | Experimental | Not described Receives: Drug: RAD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, serious adverse events, laboratory results (Hematology, Serum Blood Chemistry, hepatitis tests, Standard urinalysis dipstick assessment, Coagulation Studies)or assessment of the incidence of pneumonitis
Measured: every 6 weeks
Secondary outcomes (2)
Chest X-Ray,Triphasic CT scan or MRI of the chest, abdomen and cavitas pelvis evaluated by using RECIST criteria
Measured: 6 weeks
Date and reason of death, or discontinuation from the study.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neuroendocrine NeoplasmStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals, Study director, Novartis Investigative Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324492
- Sponsor's protocol ID
- CRAD001KCN01
- Acronym
- \MACS1304
- Status last verified
- Dec 2014
- First submitted
- 24 Mar 2011
- Last updated
- 30 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
- ClinicalTrials.gov ID
- NCT01324492
- Acronym / sponsor ID
- \MACS1304 / CRAD001KCN01
- Conditions
- Lung Neuroendocrine Neoplasm
- Keywords
- phase Ib,, RAD001,, advanced pulmonary neuroendocrine tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Mar 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.
The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 | Experimental | Drug: RAD001 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed carcinoid tumors
- Newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible
Key exclusion criteria (5 listed)
- Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis(non-clinical symptoms with brain lesions is eligible)
- Received Cytotoxic chemotherapy, immunotherapy or radiotherapy prior to enrollment
- Patients with a concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer
- Prior therapy with RAD001 or other mTOR inhibitors (sirolimus, temsirolimus, everolimus)
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| RAD001Also: Everolimus | Drug | RAD001 |
Primary outcome
Adverse events, serious adverse events, laboratory results (Hematology, Serum Blood Chemistry, hepatitis tests, Standard urinalysis dipstick assessment, Coagulation Studies)or assessment of the incidence of pneumonitis
Time frame: every 6 weeks
2 secondary outcomes
Chest X-Ray,Triphasic CT scan or MRI of the chest, abdomen and cavitas pelvis evaluated by using RECIST criteria
Time frame: 6 weeks
Date and reason of death, or discontinuation from the study.
Time frame: 12 weeks
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 30 Dec 2014.
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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
Novartis Pharmaceuticals study director
Novartis Investigative Site
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 RAD001 in people with Lung Neuroendocrine Neoplasm, run by Novartis Pharmaceuticals at 4 sites in China.
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 2 inclusion and 5 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 30 Dec 2014. 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 China. 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?
Adverse events, serious adverse events, laboratory results (Hematology, Serum Blood Chemistry, hepatitis tests, Standard urinalysis dipstick assessment, Coagulation Studies)or assessment of the incidence of pneumonitis (time frame: every 6 weeks). 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 30 Dec 2014.