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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Identification of recommended phase 2 dose of ridaforolimus in combination with bevacizumab

Outcome Time Frame:

Duration of the trial

Safety Issue:

No

Principal Investigator

Frank Haluska, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Ariad Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

AP23573-08-111

NCT ID:

NCT00781846

Start Date:

October 2008

Completion Date:

February 2010

Related Keywords:

  • Solid Tumor

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