RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms
NCT00927966
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms | |||
Official Title ICMJE | Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms | |||
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 a newly discovered drug that may stop cancer cells from growing abnormally. This drug has been extensively studied in many cancers. In particular, it has shown to be effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered drug that may stop tumor growth. It is currently being studied in a wide variety of cancers, and information from those other research studies suggests that these two drugs in combination may help to stop cancer growth. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: RAD001 in combination with figitumumab
Interventions:
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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 | Completed | |||
Actual Enrollment ICMJE | 21 | |||
Original Estimated Enrollment ICMJE | 33 | |||
Actual Study Completion Date ICMJE | January 2011 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00927966 | |||
Other Study ID Numbers ICMJE | 09-091 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Suzanne George, MD, Dana-Farber Cancer Institute | |||
Study Sponsor ICMJE | Suzanne George, MD | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | November 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |