Pancreatic CancerPhase 2NCT00409292
RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing RAD001 in people with Pancreatic Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- RAD001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2007to May 2009
- 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
- Pathologic confirmation of pancreatic adenocarcinoma
- 18 years of age or older
- At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
- Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine.
- Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease.
- Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anti-cancer therapy.
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- ECOG performance status 0-1.
- Life expectancy of greater than 12 weeks.
- Adequate bone marrow and liver function.
- Must be able to swallow tablets.
Who cannot join
- Prior treatment with an investigational drug within the preceding 4 weeks.
- Prior treatment with an inhibitor of mTOR
- Chronic treatment with systemic steroids or another immunosuppressive agent
- More than one prior chemotherapy treatment for metastatic disease
- Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases.
- Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
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- Patients with chronic renal insufficiency
- Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study.
- Known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease that my significantly alter the absorption of RAD001.
- Active, bleeding diathesis or an oral vitamin K antagonist medication
- Women who are pregnant or breast feeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.
Read the detailed description
- Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
- Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor.
- Participants will remain on the study as long as they continue to benefit from the study medication.
- Conditions
- Pancreatic Cancer
- Being tested
- RAD001
- Keywords
- RAD001, metastatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
Taken orally daily for as long as the participant continues to receive a benefit.
| Study group | Role | What they receive |
|---|---|---|
| RAD001 | Experimental | RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
Four weeks of study drug was considered to be one cycle of treatment. Receives: Drug: RAD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.
The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment.
The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population.
Measured: two months
Secondary outcomes (3)
To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer
Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. The number of patients with treatment-related adverse events are reported.
Measured: Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.
to Assess Response Rate Associated With RAD001 in This Patient Population.
The secondary objectives of the study were to assess tumor response rate and overall survival. Patients were required to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, for target lesions assessed by CT: Complete Response (CR) is Disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) equals CR + PR.
Measured: 2 years
to Assess Overall Survival Associated With RAD001 in This Patient Population.
Overall survival was defined as the time from study entry until death from any cause.
Measured: 2 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 2006 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionMay 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Novartis
- Responsible party
- Principal investigator, Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Charles Fuchs, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409292
- Sponsor's protocol ID
- 06-197
- Status last verified
- Jul 2014
- First submitted
- 6 Dec 2006
- Last updated
- 11 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Wolpin BM, Hezel AF, Abrams T, Blaszkowsky LS, Meyerhardt JA, Chan JA, Enzinger PC, Allen B, Clark JW, Ryan DP, Fuchs CS. Oral mTOR inhibitor everolimus in patients with gemcitabine-refractory metastatic pancreatic cancer. J Clin Oncol. 2009 Jan 10;27(2):193-8. doi: 10.1200/JCO.2008.18.9514. Epub 2008 Dec 1.
PubMed 19047305
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00409292
- Acronym / sponsor ID
- 06-197
- Conditions
- Pancreatic Cancer
- Keywords
- RAD001, metastatic pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Novartis
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Posted 11 Aug 2014
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 investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.
Detailed description
- Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
- Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor.
- Participants will remain on the study as long as they continue to benefit from the study medication.
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: RAD001RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent. Four weeks of study drug was considered to be one cycle of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologic confirmation of pancreatic adenocarcinoma
- 18 years of age or older
- At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
- Treated with gemcitabine-based chemotherapy with documented tumor progression on gemcitabine or intolerance to gemcitabine.
- Prior treatment with no more than 1 prior chemotherapy regimen for metastatic disease.
Key exclusion criteria (12 listed)
- Prior treatment with an investigational drug within the preceding 4 weeks.
- Prior treatment with an inhibitor of mTOR
- Chronic treatment with systemic steroids or another immunosuppressive agent
- More than one prior chemotherapy treatment for metastatic disease
- Uncontrolled brain or leptomeningeal metastases, including patient who continue to require glucocorticoids for brain or leptomeningeal metastases.
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 |
|---|---|---|
| RAD001Taken orally daily for as long as the participant continues to receive a benefit. | Drug | RAD001 |
Primary outcome
To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.
Time frame: two months
The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment. The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population.
3 secondary outcomes
To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer
Time frame: Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.
to Assess Response Rate Associated With RAD001 in This Patient Population.
Time frame: 2 years
to Assess Overall Survival Associated With RAD001 in This Patient Population.
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19047305Wolpin BM, Hezel AF, Abrams T, Blaszkowsky LS, Meyerhardt JA, Chan JA, Enzinger PC, Allen B, Clark JW, Ryan DP, Fuchs CS. Oral mTOR inhibitor everolimus in patients with gemcitabine-refractory metastatic pancreatic cancer. J Clin Oncol. 2009 Jan 10;27(2):193-8. doi: 10.1200/JCO.2008.18.9514. Epub 2008 Dec 1.
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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.
Charles Fuchs, MD 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 2 study testing RAD001 in people with Pancreatic Cancer, 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 10 inclusion and 12 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 11 Aug 2014. 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 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 11 Aug 2014). 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?
To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy. (time frame: two months). 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 NCT00409292, 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 11 Aug 2014.