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


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

whole study period

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C1104

NCT ID:

NCT00622258

Start Date:

March 2008

Completion Date:

June 2014

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • everolimus
  • mTOR inhibitor
  • non-Hodgkin's lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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