RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms

NCT00927966

Last updated date
Study Location
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sarcoma, Solid Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Sarcoma, Solid TumorRAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms
NCT00927966
  1. Boston, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • 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 doses.
  • Participants may remain on this research study as long as they do not have serious side effects or their diseae does not get worse.
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
  • Sarcoma
  • Solid Tumor
Intervention  ICMJE
  • Drug: RAD001
    Taken orally once a day.
  • Drug: CP-751,871
    Given intravenously on Day 1 of a 21-day cycle
Study Arms  ICMJE Experimental: RAD001 in combination with figitumumab
Interventions:
  • Drug: RAD001
  • Drug: CP-751,871
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
 (submitted: February 24, 2012)
21
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2009)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • Brigham and Women's Hospital
  • Novartis
  • Pfizer
Investigators  ICMJE
Principal Investigator:Suzanne George, MDDana-Farber Cancer Institute
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