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A Phase I Dose Escalation Study of RAD001 Administered in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00622258
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : September 26, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 exist.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Everolmus Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of RAD001 Administered in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Study Start Date : March 2008
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Everolimus Drug: Everolmus
Other Name: RAD001


Outcome Measures

Primary Outcome Measures :
  1. To assess the safety and tolerability of RAD001 in Japanese patients with relapsed or refractory non-Hodgkin's lymphoma [ Time Frame: whole study period ]
  2. To assess the pharmacokinetics in Japanese patients [ Time Frame: 1st sycle ]

Secondary Outcome Measures :
  1. To seek preliminary evidence of efficacy in this population [ Time Frame: Every 2 cycles ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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
  • 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

Exclusion criteria:

  • 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
  • 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622258


Locations
Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 466-8650
Novartis Investigative Site
Nagoya, Aichi, Japan, 460-0001
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Isehara-city, Kanagawa, Japan, 259-1193
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 980-8574
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Novartis Investigative Site
Fukuoka, Japan, 811-1395
Novartis Investigative Site
Kyoto, Japan, 602-8566
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00622258     History of Changes
Other Study ID Numbers: CRAD001C1104
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
everolimus
mTOR inhibitor
non-Hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents