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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 20, 2014