Non-Hodgkin's LymphomaPhase 1NCT00622258
A Phase I Dose Escalation Study of RAD001 Administered in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase 1 study testing Everolmus in people with Non-Hodgkin's Lymphoma, run by Novartis Pharmaceuticals at 8 sites in Japan.
Trial summary
This study assesses the tolerability, safety, efficacy and pharmacokinetics of everolimus in Japanese patients. Everolimus is administered orally everyday to adult patients with relapsed or refractory non-Hodgkin's lymphoma who have progressed despite standard therapy or for whom standard systemic therapy dose not… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Everolmus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 8 sitesJapan
- Study dates
- Mar 2008to Jan 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histopathologically confirmed diagnosis of non-Hodgkin's lymphoma
- Patients must have disease that is either relapsed or refractory after at least one prior treatment regimen and must not be eligible for any standard treatments
- Patients must not have received autologous stem cell transplant at least within 12 weeks prior to study treatment. If patients received autologous stem cell transplant more than 12 weeks ago, they must be fully recovered from the side effects of such treatment
- Patients who have not received autologous stem cell transplant must be either ineligible for the treatment or, if eligible, patients must have chosen not to receive stem cell transplant
- Patients must have at least one measurable lesion
- Age above 20 years old
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- Performance Status 0, 1, or 2 on Eastern Cooperative Oncology Group (ECOG) scale
- Patients with a life expectancy of at least 12 weeks
- Patients must be willing to provide portion of bone marrow aspirate and biopsy during study
Who cannot join
- Patients with history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Patients with prior allogeneic stem cell transplant
- 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
- Patients who have received radiation therapy for ≤ 28 days prior to first study treatment or who have not recovered from side effects of such therapy.
- Patients who have received any other investigational agents ≤28 days prior to the first study treatment
- Patients who have received anti-neoplastic therapy within 28 days (60 days for monoclonal antibody or radioimmunotherapy) prior to the first study treatment or who have not recovered from side effects of such therapy
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- Patients who have received treatment with oral or intravenous steroids or any immunosuppressive agents ≤ 28 days prior to the first study treatment
- Patients who have received prior therapy with RAD001 or other mTOR inhibitors
- Patient with prior therapy of > 450 U blomycin
- Patients with an active, bleeding diathesis.
- Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF) ≤ 14 days prior to the first study treatment
- Patients who have an impairment of gastrointestinal function or who have gastrointestinal disease that may significantly alter the absorption of study treatment (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
- Patients with active respiratory (excluding interstitial lung disease), skin, mucosal, renal, neurological, or ocular disorder of grade > 1
- Patients with a history of interstitial lung disease of grade ≥ 1
- Patients with a known history of human immunodeficiency virus seropositivity, hepatitis B or C seropositivity
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Novartis Investigative Site
Chuo-ku, Tokyo
Novartis Investigative Site
Fukuoka, 811-1395
Novartis Investigative Site
Isehara, Kanagawa, 259-1193
Novartis Investigative Site
Kashiwa, Chiba
Novartis Investigative Site
Kyoto, 602-8566
Novartis Investigative Site
Nagoya, Aichi-ken, 460-0001
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8650
Novartis Investigative Site
Sendai, Miyagi, 980-8574
About this study
This study assesses the tolerability, safety, efficacy and pharmacokinetics of everolimus in Japanese patients. Everolimus is administered orally everyday to adult patients with relapsed or refractory non-Hodgkin's lymphoma who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Everolmus
- Keywords
- everolimus, mTOR inhibitor, non-Hodgkin's lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolmusDrug
Also called RAD001
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | Not described Receives: Drug: Everolmus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of RAD001 in Japanese patients with relapsed or refractory non-Hodgkin's lymphoma
Measured: whole study period
To assess the pharmacokinetics in Japanese patients
Measured: 1st sycle
Secondary outcomes (1)
To seek preliminary evidence of efficacy in this population
Measured: Every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies 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
- 13 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
- NCT00622258
- Sponsor's protocol ID
- CRAD001C1104
- Status last verified
- Sep 2014
- First submitted
- 12 Feb 2008
- Last updated
- 21 Dec 2020
- Results posted
- No
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 Dose Escalation Study of RAD001 Administered in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00622258
- Acronym / sponsor ID
- CRAD001C1104
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- everolimus, mTOR inhibitor, non-Hodgkin's lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Feb 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.
This study assesses the tolerability, safety, efficacy and pharmacokinetics of everolimus in Japanese patients. Everolimus is administered orally everyday to adult patients with relapsed or refractory non-Hodgkin's lymphoma who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: Everolmus |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have histopathologically confirmed diagnosis of non-Hodgkin's lymphoma
- Patients must have disease that is either relapsed or refractory after at least one prior treatment regimen and must not be eligible for any standard treatments
- Patients must not have received autologous stem cell transplant at least within 12 weeks prior to study treatment. If patients received autologous stem cell transplant more than 12 weeks ago, they must be fully recovered from the side effects of such treatment
- Patients who have not received autologous stem cell transplant must be either ineligible for the treatment or, if eligible, patients must have chosen not to receive stem cell transplant
- Patients must have at least one measurable lesion
Key exclusion criteria (16 listed)
- Patients with history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Patients with prior allogeneic stem cell transplant
- 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
- Patients who have received radiation therapy for ≤ 28 days prior to first study treatment or who have not recovered from side effects of such therapy.
- Patients who have received any other investigational agents ≤28 days prior to the first study treatment
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 |
|---|---|---|
| EverolmusAlso: RAD001 | Drug | Everolimus |
Primary outcome
To assess the safety and tolerability of RAD001 in Japanese patients with relapsed or refractory non-Hodgkin's lymphoma
Time frame: whole study period
To assess the pharmacokinetics in Japanese patients
Time frame: 1st sycle
1 secondary outcome
To seek preliminary evidence of efficacy in this population
Time frame: Every 2 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.
- Results for CRAD001C1104 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
8 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 Everolmus in people with Non-Hodgkin's Lymphoma, run by Novartis Pharmaceuticals at 8 sites in Japan.
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 9 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: 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 8 sites in Japan. 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 assess the safety and tolerability of RAD001 in Japanese patients with relapsed or refractory non-Hodgkin's lymphoma (time frame: whole study period). 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?
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.