Status:
COMPLETED
RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms
Lead Sponsor:
Suzanne George, MD
Collaborating Sponsors:
Brigham and Women's Hospital
Novartis
Conditions:
Sarcoma
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine the safety of the combination of RAD001 and CP-751,871, as well as the highest dose of this combination that can be given to people safely. RAD001 is...
Detailed Description
* In this research study, each "cycle" of study drug dosing lasts 21 days. In the first cycle, participants will come to the clinic on Days 1, 8, and 15. During cycles 2 through 4, participants will c...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced sarcoma or other advanced malignant solid tumor for which no known curative therapy exists. Patients must have had prior progression on, intolerance or refused approved standard therapies proven to prolong life.
- Measurable disease per RECIST. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment
- 18 years of age or older
- ECOG Performance Status 0-1
- Participants must have normal organ and marrow function as outlined in the protocol
- Fully recovered from the acute effects of prior cancer therapy before initiation of study drug
- Negative urine or serum pregnancy test within 7 days prior to initiation of study drug for women of child-bearing potential
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for up to 6 months after the last dose of study drug
Exclusion
- Participants with gastrointestinal tumors (GIST) on approved tyrosine kinase inhibitors within 2 weeks prior to study entry
- All other participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin C) prior to study entry
- Participants who have had radiotherapy and/or major surgery within 2 weeks prior to study entry
- Concurrent use of any other anti-cancer therapies, study agents, growth hormones, growth hormone inhibitors or aminoglycoside antibiotics
- Participants who have had chronic high dose immunosuppressive steroid therapy within 2 weeks prior to enrollment. Previous high dose steroid treatment \> 2 weeks prior to study entry, topical and inhaled corticosteroids are allowed
- Presence of symptomatic or uncontrolled brain or central nervous system metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001 and/or CP-751,871
- Participants receiving any medications or substances that are inhibitors or inducers of CYP3A
- Uncontrolled diabetes
- Bleeding diathesis or requirement for therapeutic anticoagulation
- Uncontrolled intercurrent illness
- Pregnant or nursing women
- HIV positive individuals on combination anti-retroviral therapy
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00927966
Start Date
July 1 2009
End Date
January 1 2011
Last Update
November 14 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115