Clinical trial NCT00688753: RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe
Official title: A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma
Renal Cell
Non Clear Cell Renal Carcinoma
Papillary Cell Renal Carcinoma
Adenocarcinoma
Keywords: renal cell carcinoma
non clear cell carcinoma
papillary cell renal carcinoma
adults
everolimus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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:

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 excipients.
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.

Primary outcomes:
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.
timeFrame: 6 mos
Secondary outcomes:
measure: Disease Control Rate (SD + PR + CR)
timeFrame: 6 mos
measure: Objective Response Rate
timeFrame: End of trial
measure: Duration of Response
timeFrame: End of trial
measure: Median Progression Free Survival
timeFrame: End of trial
measure: Incidence of Adverse Events, Serious Adverse Events, and Death.
timeFrame: End of trial
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Lyon Cedex
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Villejuif Cedex
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Arezzo
country: Italy
facility: Novartis Investigative Site
state: AR
city: Cremona
country: Italy
facility: Novartis Investigative Site
state: CR
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Otwock
country: Poland
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Barcelona
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Escudier B, Molinie V, Bracarda S, Maroto P, Szczylik C, Nathan P, Negrier S, Weiss C, Porta C, Grunwald V, Albiges L. Open-label phase 2 trial of first-line everolimus monotherapy in patients with papillary metastatic renal cell carcinoma: RAPTOR final analysis. Eur J Cancer. 2016 Dec;69:226-235. doi: 10.1016/j.ejca.2016.08.004. Epub 2016 Sep 24.