Clinical trial · Interventional
Trial of Deforolimus in Combination With Bevacizumab for Patients With Advanced Cancers (8669-010)(COMPLETED)
A Phase I Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Bevacizumab for Patients With Advanced Cancers
NCT00781846CI-TRIAL-00016863completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| ridaforolimus | Drug | Ridaforolimus | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- 30mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
- interventionNames
- Drug: ridaforolimus
- Drug: bevacizumab
- type
- EXPERIMENTAL
- label
- 2
- description
- 40mg QDx5/wk ridaforolimus plus 10mg/kg Q2wks bevacizumab for 4 weeks
- interventionNames
- Drug: ridaforolimus
- Drug: bevacizumab
- type
- EXPERIMENTAL
- label
- 3
- description
- 40mg QDx5/wk ridaforolimus plus 15mg/kg Q3wks bevacizumab for 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTNemunaitis 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 Jun;25(6):336-42. doi: 10.1016/j.clon.2013.02.005. Epub 2013 Apr 21. PMID 23615181