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

December 17, 2020 updated by: Novartis Pharmaceuticals
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 811-1395
        • Novartis Investigative Site
      • Kyoto, Japan, 602-8566
        • Novartis Investigative Site
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • Novartis Investigative Site
      • Nagoya-city, Aichi, Japan, 466-8650
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, Japan
        • Novartis Investigative Site
    • Kanagawa
      • Isehara-city, Kanagawa, Japan, 259-1193
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japan, 980-8574
        • Novartis Investigative Site
    • Tokyo
      • Chuo-ku, Tokyo, Japan
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Everolimus
Drug: Everolmus
Other Names:
  • RAD001

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To seek preliminary evidence of efficacy in this population
Time Frame: Every 2 cycles
Every 2 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (ESTIMATE)

February 22, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001C1104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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