Non-Small Cell Lung CancerPhase 1RAD001NCT01063478
Dose Escalation Study of RAD001 in Combination w/Chemotherapy & Radiation in Patients With NSCLC
A Phase 1 study testing RAD001 (in addition to standard radiation and chemotherapy) in people with Non-Small Cell Lung Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to understand the effects (good and/or bad) of the addition of RAD001 to standard radiation and chemotherapy (cisplatin and pemetrexed) for patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- RAD001 (in addition to standard radiation and chemotherapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jan 2012
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC of any type
- Disease stage. Patients with unresectable stage II, stage III, and Mx are eligible. This includes patients who are being considered as surgical candidates after induction chemoradiation. Patients with Mx or M1 disease whose life-span and prognosis are felt to be dominated by the locoregional disease in the chest and are candidates for chemoradiotherapy are also eligible.
- Patients with pleural effusion that is transudative, cytologically negative and non- bloody are eligible if the radiation oncologist feels that the tumor can be encompassed within a reasonable field of radiotherapy.
- If a pleural effusion is of such a small size that a thoracentesis is not possible, then the patient is eligible
- Patients with malignant pleural or pericardial effusions are not eligible
- Patients will be eligible with or without measurable or evaluable disease. Patients with both measurable and evaluable disease will be evaluated for criteria for measurable disease
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- Measurable disease is defined according to RECIST criteria
- Evaluable disease is defined as lesions apparent on CT which do not fit criteria for measurability.
- Ill defined masses associated with post obstructive changes
- Mediastinal or hilar adenopathy measurable in only one dimension
- Age ≥ 18 years
- ECOG performance status ≤ 2
- Life expectancy > 6 months
- Adequate lung function as defined by an 02 saturation that is ≥ 90% on room air
- Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb >9 g/dL Adequate liver function as shown by: serum bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases), INR and PTT ≤1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks at time of randomization.)
- Adequate renal function: serum creatinine ≤ 1.5 x ULN
- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- Informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document.
- Radiation therapy requirements: Patient must have a completed treatment plan approved by the protocol review team
Who cannot join
- Patients who have received prior radiation or chemotherapy for the current diagnosis of NSCLC (patients who received surgery only for a prior NSCLC are eligible if the current diagnosis is felt to represent a new primary, and the PFT's would allow for concurrent chemoradiation)
- Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
- Prior treatment with any investigational drug within the preceding 4 weeks
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
- Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or breast DCIS, who may be included if the diagnosis was within 3 years.
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- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
- unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug
- serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
- symptomatic congestive heart failure of New York heart Association Class III or IV
- uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
- active (acute or chronic) or uncontrolled severe infections
- liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- A known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- Patients with an active, bleeding diathesis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: A Phase I Dose Escalation Study of RAD001 in Combination With Chemotherapy and Radiation in Patients With NSCLC
The purpose of this study is to understand the effects (good and/or bad) of the addition of RAD001 to standard radiation and chemotherapy (cisplatin and pemetrexed) for patients with non-small cell lung cancer.
Read the detailed description
In oncology, clinical experience with RAD001 has been based on a number of phase I and II studies with single agent RAD001 as well as phase Ib and II studies of RAD001 in combination with other chemotherapeutic and molecular targeted agents, including paclitaxel, gemcitabine, and erlotinib among others. More recently, a phase III trial of single agent RAD001 in patients with metastatic renal cell carcinoma who had failed therapy with VEGF tyrosine kinase inhibitors was completed. Clinical experience for indications other than oncology comes from single dose studies in healthy volunteers, and studies in solid organ transplant patients, where RAD001 was administered with other immunosuppressive agents.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- RAD001 (in addition to standard radiation and chemotherapy)
- Keywords
- Non-Small Cell, Lung Cancer, Unresectable advanced NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001 (in addition to standard radiation and chemotherapy)Drug
Also called RAD001 (Everolimus)
Standard radiation and chemotherapy (cisplatin and pemetrexed) + RAD001
| Study group | Role | What they receive |
|---|---|---|
| RAD001, Chemotherapy, Radiation | Experimental | RAD001 + Chemotherapy and Radiation Receives: Drug: RAD001 (in addition to standard radiation and chemotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of RAD001 when administered in combination with chemotherapy and radiation.
Measured: 9/2011
Secondary outcomes (1)
To evaluate the preliminary clinical benefit rate after administration of RAD001 in combination with chemotherapy and radiation.
Measured: 3/2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionJan 2012
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Everett E Vokes, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063478
- Sponsor's protocol ID
- 09-384-B
- Acronym
- RAD001
- Status last verified
- Jan 2014
- First submitted
- 3 Feb 2010
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of RAD001 in Combination With Chemotherapy and Radiation in Patients With NSCLC
- ClinicalTrials.gov ID
- NCT01063478
- Acronym / sponsor ID
- RAD001 / 09-384-B
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell, Lung Cancer, Unresectable advanced NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 5 Feb 2010 (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 study is to understand the effects (good and/or bad) of the addition of RAD001 to standard radiation and chemotherapy (cisplatin and pemetrexed) for patients with non-small cell lung cancer.
Detailed description
In oncology, clinical experience with RAD001 has been based on a number of phase I and II studies with single agent RAD001 as well as phase Ib and II studies of RAD001 in combination with other chemotherapeutic and molecular targeted agents, including paclitaxel, gemcitabine, and erlotinib among others. More recently, a phase III trial of single agent RAD001 in patients with metastatic renal cell carcinoma who had failed therapy with VEGF tyrosine kinase inhibitors was completed. Clinical experience for indications other than oncology comes from single dose studies in healthy volunteers, and studies in solid organ transplant patients, where RAD001 was administered with other immunosuppressive agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001, Chemotherapy, Radiation | Experimental | Drug: RAD001 (in addition to standard radiation and chemotherapy)RAD001 + Chemotherapy and Radiation |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically or cytologically confirmed NSCLC of any type
- Disease stage. Patients with unresectable stage II, stage III, and Mx are eligible. This includes patients who are being considered as surgical candidates after induction chemoradiation. Patients with Mx or M1 disease whose life-span and prognosis are felt to be dominated by the locoregional disease in the chest and are candidates for chemoradiotherapy are also eligible.
- Patients with pleural effusion that is transudative, cytologically negative and non- bloody are eligible if the radiation oncologist feels that the tumor can be encompassed within a reasonable field of radiotherapy.
- If a pleural effusion is of such a small size that a thoracentesis is not possible, then the patient is eligible
- Patients with malignant pleural or pericardial effusions are not eligible
Key exclusion criteria (16 listed)
- Patients who have received prior radiation or chemotherapy for the current diagnosis of NSCLC (patients who received surgery only for a prior NSCLC are eligible if the current diagnosis is felt to represent a new primary, and the PFT's would allow for concurrent chemoradiation)
- Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
- Prior treatment with any investigational drug within the preceding 4 weeks
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
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 |
|---|---|---|
| RAD001 (in addition to standard radiation and chemotherapy)Also: RAD001 (Everolimus)Standard radiation and chemotherapy (cisplatin and pemetrexed) + RAD001 | Drug | RAD001, Chemotherapy, Radiation |
Primary outcome
To evaluate the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of RAD001 when administered in combination with chemotherapy and radiation.
Time frame: 9/2011
1 secondary outcome
To evaluate the preliminary clinical benefit rate after administration of RAD001 in combination with chemotherapy and radiation.
Time frame: 3/2012
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 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.
Everett E Vokes, MD principal investigator
University of Chicago
1 site 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 addition to standard radiation and chemotherapy) in people with Non-Small Cell Lung Cancer, run by University of Chicago at 1 site 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 19 inclusion and 16 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: stopped early, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Poor accrual). Results are not available in the source record.
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 evaluate the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of RAD001 when administered in combination with chemotherapy and radiation. (time frame: 9/2011). 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 17 Jan 2014.