| October 28, 2008 |
| August 27, 2009 |
| October 2008 |
| February 2010 (final data collection date for primary outcome measure) |
| Identification of recommended phase 2 dose of deforolimus in combination with bevacizumab [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00781846 on ClinicalTrials.gov Archive Site |
- Characterize the overall safety and tolerability of deforolimus in combination with bevacizumab [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
- Description of the anti-tumor activity of deforolimus in combination with bevacizumab [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Trial of Deforolimus in Combination With Bevacizumab for Patients With Advanced Cancers |
| A Phase I Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Bevacizumab for Patients With Advanced Cancers |
The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose of oral deforolimus administered in combination with intravenous bevacizumab in patients with advanced cancers. |
| |
| Phase I |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Solid Tumor |
| Drug: ridaforolimus |
| Experimental: deforolimus 20, 30 or 40 mg oral tablets daily for 5 days/week and bevacizumab 10 mg/kg IV every 2 weeks or 15mg/kg IV every 3 weeks |
| |
| |
| Active, not recruiting |
| 15 |
| February 2010 |
| February 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00781846 |
| Frank Haluska, MD, PhD, Vice President, Clinical Research, ARIAD Pharmaceuticals, Inc. |
| AP23573-08-111 |
| Ariad Pharmaceuticals |
| Merck |
| Study Director: |
Frank Haluska, MD, PhD |
Ariad Pharmaceuticals |
|
|
| Ariad Pharmaceuticals |
| August 2009 |