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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00622258
First received: February 12, 2008
Last updated: June 19, 2014
Last verified: June 2014

February 12, 2008
June 19, 2014
March 2008
January 2014   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
  • To assess the pharmacokinetics in Japanese patients [ Time Frame: 1st sycle ] [ Designated as safety issue: No ]
To assess the safety and tolerability of RAD001 in Japanese patients with relapsed or refractory non-Hodgkin's lymphoma To assess pharmacokinetics in Japanese patients [ Time Frame: First cycle ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00622258 on ClinicalTrials.gov Archive Site
To seek preliminary evidence of efficacy in this population [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase I Dose Escalation Study of RAD001 Administered in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase I Dose Escalation Study of RAD001 Administered in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: Everolmus
Other Name: RAD001
Experimental: Everolimus
Intervention: Drug: Everolmus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
January 2014
January 2014   (final data collection date for primary outcome measure)

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

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00622258
CRAD001C1104
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP