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Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms

Phase 1
18 Years
Not Enrolling
Sarcoma, Solid Tumor

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Trial Information

Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms

- 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 come to the clinic on Days 1 and 8. The rest of the
clinic visits will occur on Day 1 of every cycle thereafter.

- During each cycle, participants will take RAD001 orally, once a day in the morning. In
addition, participants will receive CP-751,871 intravenously once every cycle on the
first day of each cycle.

- Since we are looking for the highest dose of the study drug that can be administered
safely without severe or unmanageable side effects, not everyone who participates in
this research study will receive the same dose of the study drug. The dose will depend
on the number of participants enrolled in the study and how well they tolerated their

- Participants may remain on this research study as long as they do not have serious side
effects or their diseae does not get worse.

Inclusion Criteria:

- 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 Criteria:

- 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

Type of Study:


Study Design:

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

Outcome Measure:

To assess the safety and tolerability of daily oral RAD001, administered in combination with CP-751,871 given as an intravenous infusion in patients with advanced sarcomas and other advanced solid tumors that are incurable with any current modality.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Suzanne George, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

January 2011

Related Keywords:

  • Sarcoma
  • Solid Tumor
  • RAD001
  • CP-751,871
  • advanced sarcoma
  • advanced malignant solid tumor
  • Neoplasms
  • Sarcoma



Dana-Farber Cancer Institute Boston, Massachusetts  02115