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

Solid Tumor Clinical Trial

Official title:

A Phase I Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Bevacizumab for Patients With Advanced Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781846
• Other study ID #: 8669-010
• Secondary ID: AP23573-08-111
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2008
• Last updated: February 12, 2015
• Start date: October 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• ridaforolimus
oral tablets, daily for 5 days/week
• bevacizumab
IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Ariad Pharmaceuticals

References & Publications (1)

Nemunaitis J, Hochster HS, Lustgarten S, Rhodes R, Ebbinghaus S, Turner CD, Dodion PF, Mita MM. A phase I trial of oral ridaforolimus (AP23573; MK-8669) in combination with bevacizumab for patients with advanced cancers. Clin Oncol (R Coll Radiol). 2013 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab		Duration of the trial	No
Secondary	Characterize the overall safety and tolerability of ridaforolimus in combination with bevacizumab		Duration of the study	Yes
Secondary	Description of the anti-tumor activity of ridaforolimus in combination with bevacizumab		Duration of the study	No