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Trial of Deforolimus in Combination With Bevacizumab for Patients With Advanced Cancers
This study is ongoing, but not recruiting participants.
Study NCT00781846   Information provided by Ariad Pharmaceuticals
First Received: October 28, 2008   Last Updated: August 27, 2009   History of Changes

October 28, 2008
August 27, 2009
October 2008
February 2010   (final data collection date for primary outcome measure)
Identification of recommended phase 2 dose of deforolimus in combination with bevacizumab [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00781846 on ClinicalTrials.gov Archive Site
  • Characterize the overall safety and tolerability of deforolimus in combination with bevacizumab [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
  • Description of the anti-tumor activity of deforolimus in combination with bevacizumab [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
Same as current
 
Trial of Deforolimus in Combination With Bevacizumab for Patients With Advanced Cancers
A Phase I Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Bevacizumab for Patients With Advanced Cancers

The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose of oral deforolimus administered in combination with intravenous bevacizumab in patients with advanced cancers.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment
Solid Tumor
Drug: ridaforolimus
Experimental: deforolimus 20, 30 or 40 mg oral tablets daily for 5 days/week and bevacizumab 10 mg/kg IV every 2 weeks or 15mg/kg IV every 3 weeks
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
15
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • Advanced or metastatic solid tumor malignancy
  • ECOG performance status of less than or equal to 1
  • Life expectancy of greater than 3 months
  • At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy, or radiotherapy, and the first dose of deforolimus
  • Adequate hematological, hepatic and renal function
  • Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL
  • Signed informed consent
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days of starting therapy and must use an approved contraceptive method from time of screening until 30 days after the last dose of study drug

Exclusion Criteria:

  • Tumor location in close proximity to a major blood vessel
  • History of brain metastases, spinal cord compression, or carcinomatous meningitis. Primary brain tumors (for example, glioblastoma) are allowed.
  • New brain metastases, spinal cord compression, or leptomeningeal metastases on screening CT scan or MRI
  • Hemoptysis or hematemesis within 28 days prior to entering the trial
  • Clinical significant unexplained bleeding within 28 days prior to entering the trial
  • Uncontrolled hypertension
  • Proteinuria at screening
  • Clinically significant cardiovascular disease
  • Newly diagnosed or poorly controlled type 1 or 2 diabetes
  • Active infection requiring prescribed intervention
  • Other concurrent illness that, in the Investigator's judgement, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
  • Major surgery within 28 days before trial entry, or any incompletely healed surgical incision; minor surgery or procedures within 7 days
  • Pregnant or breastfeeding
  • Known allergy to macrolide antibiotics
  • Known hypersensitivity to any component of bevacizumab
  • Concurrent treatment with medications that strongly induce or inhibit cytochrome P450 (CYP3A)
  • Known history of HIV sero-positivity
  • Any condition in the Investigator's judgement that renders the patient unable to fully understand and provide informed consent and/or comply with the protocol
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00781846
Frank Haluska, MD, PhD, Vice President, Clinical Research, ARIAD Pharmaceuticals, Inc.
AP23573-08-111
Ariad Pharmaceuticals
Merck
Study Director: Frank Haluska, MD, PhD Ariad Pharmaceuticals
Ariad Pharmaceuticals
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP