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

Sponsor:	Merck
Collaborator:	Ariad Pharmaceuticals
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00781846

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 I

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:

MedlinePlus related topics: Cancer

Drug Information available for: Bevacizumab AP 23573

U.S. FDA Resources

Further study details as provided by Merck:

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

Ariad Pharmaceuticals

Investigators

Study Director:

Frank Haluska, MD, PhD

Ariad Pharmaceuticals

More Information

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00781846 History of Changes
Other Study ID Numbers:	AP23573-08-111
Study First Received:	October 28, 2008
Last Updated:	July 7, 2011
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 February 09, 2012