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

Sponsor:	Novartis Pharmaceuticals
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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Sirolimus Everolimus CCI 779

U.S. FDA Resources

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 ]
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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	75
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Everolimus - sarcoma ( not recruiting) patients with progressive or metastatic bone or soft tissue sarcoma (except for GIST),	Drug: Everolimus/RAD001 10 mg orally Other Name: Afinitor
Experimental: Everolimus - GIST (not recruiting) 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 Other Name: Afinitor
Experimental: Everolimus - ASPS (currently recruiting) patients with ASPS	Drug: Everolimus/RAD001 10 mg orally Other Name: Afinitor

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)
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

Contacts and Locations

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

Contacts

Contact: Novartis Pharmaceuticals

+1 800-340-6843

Locations

Germany
Novartis Investigative Site	Recruiting
Berlin, Germany
Novartis Investigative Site	Recruiting
Dusseldorf, Germany
Novartis Investigative Site	Recruiting
Essen, Germany
Novartis Investigative Site	Recruiting
Mannheim, Germany
Novartis Investigative Site	Recruiting
Munich, Germany
Italy
Novartis Investigative Site	Recruiting
Milan, Italy

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00767819 History of Changes
Other Study ID Numbers:	CRAD001C24114, EUDRACT- Nr. 2007-005294-60
Study First Received:	October 6, 2008
Last Updated:	February 1, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Italy: AIFA- Ufficio sperimentazioni cliniche

Keywords provided by Novartis:

progressive GIST
progressive sarcoma

Additional relevant MeSH terms:

Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 13, 2012