Treatment of Patients With RAD001 Who Have Progressive Sarcoma

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00767819

First received: October 6, 2008

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2008

Last Updated Date

January 29, 2013

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Preliminary efficacy of RAD001 in progressive or metastatic bone and soft tissue sarcoma (except for GIST) defined as the proportion complete response, partial response or stable disease at 16 weeks. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Preliminary efficacy of RAD001 in patients with GIST after failure or intolerance of treatment with imatinib or sunitinib in 1st and 2nd line defined as the proportion of patients showing complete response, partial response or stable disease at 16 weeks. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate preliminary efficacy of RAD001 in progressive or metastatic alveolar soft part sarcoma (ASPS). Efficacy is defined as the proportion of patients showing complete response, partial response or stable disease at 16 weeks. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00767819 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the tolerability and safety profile of RAD001 in these patient populations. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate the objective tumor response rate based on RECIST-criteria (complete response [CR] and partial response [PR]) at 16 weeks. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate duration of response [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate progression-free survival (PFS) at 16 weeks. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate overall survival (OS). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate PFS at month 12 for patients with data available from follow-up observation (optional). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To evaluate OS at 12 months for patients with data available from follow-up observation (optional). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety and tolerability of RAD001 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
OR after 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
PFS after 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Patients With RAD001 Who Have Progressive Sarcoma

Official Title ^ICMJE

Multicenter, Triple-arm, Single-stage, Phase II Trial to Determine the Preliminary Efficacy and Safety of RAD001 in Patients With Histological Evidence of Progressive or Metastatic Bone or Soft Tissue Sarcomas

Brief Summary

The purpose of this multicenter, two-arm, exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Progressive Sarcoma

Intervention ^ICMJE

Drug: Everolimus/RAD001

10 mg orally

Other Name: Afinitor

Study Arm (s)

Experimental: 1 = GIST
Intervention: Drug: Everolimus/RAD001
Experimental: 2 = Sarkoma
Intervention: Drug: Everolimus/RAD001
Experimental: 3 = ASPS
Intervention: Drug: Everolimus/RAD001

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histological evidence of progressive or metastatic bone or soft tissue sarcoma.

The following tumor types are included:

malignant fibrous histiocytoma
liposarcoma
synovial sarcoma
malignant paraganglioma
fibrosarcoma
leiomyosarcoma
angiosarcoma including haemangiopericytoma
malignant peripheral nerve sheath tumor
STS, not otherwise specified
miscellaneous sarcoma including mixed mesodermal tumors of the uterus
osteosarcoma
Ewing's sarcoma
rhabdomyosarcoma
gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line)
alveolar soft part sarcoma (ASPS)
- Objective progression of disease may be documented by RECIST criteria. Any of the following would be sufficient according to RECIST:
a 20% increase in the sum of unidimensionally measured target lesions
a new lesion
unequivocal increase in non-measurable disease.
- Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
- ECOG performance status 0 - 2.

Exclusion Criteria:

Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy.

The following tumor types will not be included:
- gastrointestinal stromal tumor (except for patients after treatment with imatinib or sunitinib in 1st and 2nd line)
- chondrosarcoma
- malignant mesothelioma
- neuroblastoma.
Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
Neurotoxicity > grade 2 CTC.
Radiation of the lung.

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Italy

Administrative Information

NCT Number ^ICMJE

NCT00767819

Other Study ID Numbers ^ICMJE

CRAD001C24114, 2007-005294-60, EUDRACT- Nr. 2007-005294-60

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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