Phase 2
N=92
RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe
Carcinoma · Renal Cell · Non Clear Cell Renal Carcinoma · Papillary Cell Renal Carcinoma · Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00688753 ↗Enrolled (actual)
92
Serious AEs
46.7%
Results posted
Nov 2015
Primary outcome: Primary: 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. — 34.1; 33.3; 32.6 % participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RAD001 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
34.1; 33.3; 32.6 | — |
| SECONDARY Disease Control Rate (SD + PR + CR) |
65.2; 65.1 | — |
| SECONDARY Objective Response Rate |
1.5; 1.2 | — |
| SECONDARY Duration of Response |
169; 226 | — |
| SECONDARY Median Progression Free Survival |
118; 113 | — |
| SECONDARY Incidence of Adverse Events, Serious Adverse Events, and Death. |
100; 97.83; 53.26; 27.17; 90.22; 46.74 | — |
Summary
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.
Eligibility Criteria
Inclusion criteria
- ≥ 18 years old.
- Patients with metastatic papillary renal cell carcinoma, type I or II.
- Patients with at least one measurable lesion.
- Patients with an ECOG Performance Status ≤1.
- Adequate bone marrow function.
- Adequate liver function.
- Adequate renal function.
- Adequate lipid profile.
Exclusion criteria
- Patients who had radiation therapy within 28 days prior to start of study.
- Patients who have received prior systemic treatment for their metastatic RCC.
- Patients who received prior therapy with VEGF pathway inhibitor.
- Patients who have previously received systemic mTOR inhibitors.
- Patients with a known hypersensitivity everolimus or other rapamycins or to its excipients.
- Patients with uncontrolled central nervous system (CNS) metastases.
- Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
- Patients with a known history of HIV seropositivity.
- Patients with autoimmune hepatitis.
- Patients with an active, bleeding diathesis.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
- 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.
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
- Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
- Patients unwilling to or unable to comply with the protocol.
Data sourced from ClinicalTrials.gov (NCT00688753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.