Treatment of Patients With RAD001 Who Have Progressive Sarcoma - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00767819

Purpose

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.

Condition	Intervention	Phase
Progressive Sarcoma	Drug: Everolimus/RAD001	Phase II

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Multicenter, Single-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

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental patients with progressive or metastatic bone or soft tissue sarcoma (except for GIST),	Drug: Everolimus/RAD001 10 mg orally
2: Experimental patients with progressive or metastatic GIST after failure or intolerance of treatment with imatinib or sunitinib in 1st and 2nd line	Drug: Everolimus/RAD001 10 mg orally

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)
- 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767819

Contacts

Contact: Novartis Basel	+41 61 324 1111
Contact: Novartis US	862-778-8300

Locations

Germany
Novartis Investigative Site	Recruiting
Berlin, Germany
Novartis Investigative Site	Recruiting
Munich, Germany
Novartis Investigative Site	Recruiting
Dusseldorf, Germany
Novartis Investigative Site	Recruiting
Mannheim, Germany

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CRAD001C24114, EUDRACT- Nr. 2007-005294-60
Study First Received:	October 6, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767819
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices (BfArM)

Keywords provided by Novartis:

progressive GIST
progressive sarcoma

Study placed in the following topic categories:

Everolimus
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009