Trial of Deforolimus in Combination With Bevacizumab for Patients With Advanced Cancers (8669-010)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00781846
First received: October 28, 2008
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Solid Tumor
Drug: ridaforolimus
Drug: bevacizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Bevacizumab for Patients With Advanced Cancers

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the overall safety and tolerability of ridaforolimus in combination with bevacizumab [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
  • Description of the anti-tumor activity of ridaforolimus in combination with bevacizumab [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
Drug: ridaforolimus
oral tablets, daily for 5 days/week
Other Names:
  • deforolimus
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: bevacizumab
IV infusion
Other Name: avastin
Experimental: 2
40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
Drug: ridaforolimus
oral tablets, daily for 5 days/week
Other Names:
  • deforolimus
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: bevacizumab
IV infusion
Other Name: avastin
Experimental: 3
40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks
Drug: ridaforolimus
oral tablets, daily for 5 days/week
Other Names:
  • deforolimus
  • AP23573
  • MK-8669
  • ridaforolimus was also known as deforolimus until May 2009
Drug: bevacizumab
IV infusion
Other Name: avastin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781846

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Ariad Pharmaceuticals
Investigators
Study Director: Frank Haluska, MD, PhD Ariad Pharmaceuticals
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00781846     History of Changes
Other Study ID Numbers: 8669-010, AP23573-08-111
Study First Received: October 28, 2008
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bevacizumab
Sirolimus
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 14, 2014