RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe

Carcinoma Clinical Trial

— MACS0460  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688753
• Other study ID #: CRAD001LFR08
• Secondary ID: 2008-006181-28
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2008
• Last updated: October 21, 2015
• Start date: July 2009
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium:Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten / Agence Fédérale des Médicaments et des Produits de SantéFrance:Agence Francaise des Sécurité Sanitaire des Produits de SantéGermany:Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)Italy:Agenzia Italiana del Farmaco (AIFA)Poland:Urzad Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów BiobójczychSpain:Agencia Española del MedicamentoUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Renal Cell
• Kidney Neoplasms
• Non Clear Cell Renal Carcinoma
• Papillary Cell Renal Carcinoma
• Renal Cell

Intervention

Drug:
• RAD001

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Brussels
Belgium	Novartis Investigative Site	Gent
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Lyon Cedex
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Villejuif Cedex
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Muenster
Italy	Novartis Investigative Site	Arezzo	AR
Italy	Novartis Investigative Site	Cremona	CR
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Pavia	PV
Poland	Novartis Investigative Site	Otwock
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	PFSR at 6 months based on central review	6 mos	No
Secondary	Disease Control Rate (SD + PR + CR)	DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR	6 mos	No
Secondary	Objective Response Rate	ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression	End of trial	No
Secondary	Duration of Response	The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.	End of trial	No
Secondary	Median Progression Free Survival	PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.	End of trial	No
Secondary	Incidence of Adverse Events, Serious Adverse Events, and Death.		End of trial	Yes