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A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Renal Cell, Non Clear Cell Renal Carcinoma, Papillary Cell Renal Carcinoma, Adenocarcinoma

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Trial Information

A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer

Inclusion Criteria

Inclusion criteria:

1. ≥ 18 years old.

2. Patients with metastatic papillary renal cell carcinoma, type I or II.

3. Patients with at least one measurable lesion.

4. Patients with an ECOG Performance Status ≤1.

5. Adequate bone marrow function.

6. Adequate liver function.

7. Adequate renal function.

8. Adequate lipid profile.

Exclusion criteria:

1. Patients who had radiation therapy within 28 days prior to start of study.

2. Patients who have received prior systemic treatment for their metastatic RCC.

3. Patients who received prior therapy with VEGF pathway inhibitor.

4. Patients who have previously received systemic mTOR inhibitors.

5. Patients with a known hypersensitivity everolimus or other rapamycins or to its

6. Patients with uncontrolled central nervous system (CNS) metastases.

7. Patients receiving chronic systemic treatment with corticosteroids or another
immunosuppressive agent.

8. Patients with a known history of HIV seropositivity.

9. Patients with autoimmune hepatitis.

10. Patients with an active, bleeding diathesis.

11. Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study.

12. Patients who have a history of another primary malignancy and off treatment ≤ 3
years, with the exception of non-melanoma skin cancer and carcinoma in situ of the
uterine cervix.

13. Female patients who are pregnant or breast feeding, or adults of reproductive
potential who are not using effective birth control methods.

14. Patients who are using other investigational agents or who had received
investigational drugs ≤ 4 weeks prior to study treatment start.

15. Patients unwilling to or unable to comply with the protocol.

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate efficacy of RAD001 as monotherapy for the treatment of papillary renal cancer. Efficacy is defined as the percentage of patients progression-free at 6 months.

Outcome Time Frame:

Every 8 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

December 2013

Related Keywords:

  • Carcinoma
  • Renal Cell
  • Non Clear Cell Renal Carcinoma
  • Papillary Cell Renal Carcinoma
  • Adenocarcinoma
  • renal cell carcinoma
  • non clear cell carcinoma
  • papillary cell renal carcinoma
  • adults
  • everolimus
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms