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

NCT00622258 | Completed Phase 1

• 1 other identifier: CRAD001C1104
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 8

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.

Conditions

Non-Hodgkin's Lymphoma

Keywords

everolimus; mTOR inhibitor; non-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (2)

• To assess the safety and tolerability of RAD001 in Japanese patients with relapsed or refractory non-Hodgkin's lymphoma

  whole study period

• To assess the pharmacokinetics in Japanese patients

  1st sycle

Secondary Outcomes (1)

• To seek preliminary evidence of efficacy in this population

  Every 2 cycles

Study Arms (1)

Everolimus

EXPERIMENTAL

Drug: Everolmus

Interventions

Everolmus DRUG

Also known as: RAD001

Everolimus

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Nagoya, Aichi-ken, 460-0001, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 466-8650, Japan

Location

Novartis Investigative Site

Kashiwa, Chiba, Japan

Location

Novartis Investigative Site

Isehara, Kanagawa, 259-1193, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 980-8574, Japan

Location

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Location

Novartis Investigative Site

Fukuoka, 811-1395, Japan

Location

Novartis Investigative Site

Kyoto, 602-8566, Japan

Location

Related Links

• Results for CRAD001C1104 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 21, 2020

Record last verified: 2014-09

Locations

JP (8)