- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00496600
Phase I Study of Patupilone and RAD001
Phase I Study of Patupilone and RAD001 in Patients With Refractory Solid Tumor Malignancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Endpoint To identify the maximum tolerated doses (MTD) of the combination of patupilone and RAD001
Secondary Endpoints To assess the toxicity of patupilone and RAD001 To determine if concentrations of RAD001 are elevated in the presence of patupilone To evaluate tumor response using standard imaging modalities (CT scan, x-ray, bone scan) To develop pharmacodynamic markers that may predict or indicate response to mTOR inhibition or patupilone treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New Jersey
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New Brunswick, New Jersey, United States, 08901
- The Cancer Institute of New Jersey
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients must have malignancy refractory to standard therapy or for whom no standard, effective therapy is available.
- Patient must have performance status 0-2 on the ECOG Performance Status (see Appendix B)
- Patient's disease must be measurable (RECIST) or evaluable (e.g., cytologically or radiologically detectable disease such as ascites, peritoneal deposits, or lesions which do not fulfill RECIST criteria for measurable disease).
- Patients must have intact intestinal absorption
- Patients must have adequate organ function
- Patient must have recovered from toxicity of prior chemotherapy and/or radiotherapy. Patient may not have received chemotherapy in the prior 4 weeks. Patients may have not received radiotherapy in the prior 3 weeks.
- Patient (male or female) must be ≥ 18 years old.
- Women must not be pregnant or lactating. Female patients of childbearing potential must have a negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study, and for three months following discontinuation of study drug.
- Signed written informed consent.
Exclusion Criteria:
- Patient has received greater than 3 prior cytotoxic regimens for metastatic disease.
- Prior therapy with epothilones, rapamycin, rapamycin analogs, or known sensitivity to these agents
- Prior treatment with any investigational drug within the preceding 4 weeks.
- Patient has history of bone marrow or stem cell transplant.
- Patient has received prior radiation therapy to greater than 25% of the bone marrow.
- Patients has newly diagnosed, not yet treated or uncontrolled brain metastases or leptomeningeal disease.
- Patient has known hypersensitivity to the components of study drugs or its analogs.
- Patient with known Grade 3 or 4 hypersensitivity to macrolide antibiotics (eg. clarithromycin, erythromycin, azithromycin).
- Patient with any active (acute or chronic) or uncontrolled infection requiring systemic therapy.
- Patients with chronic treatment with systemic steroids or another immunosuppressive agent
- Patient with known HIV infection.
- Patients with unresolved diarrhea within the last 7 days prior to start of treatment.
- Concomitant treatment with medications that are listed as clinically relevant inducers or inhibitors of cytochrome P450 (CYP3A).
- Patients taking Coumadin® or other agents containing warfarin, with the exception of low dose Coumadin® (1 mg or less) administered prophylactically for maintenance of in-dwelling lines or ports
- Herbal preparations or related over-the-counter preparations containing herbal ingredients (eg. St. John's Wort)
- Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia, or severely impaired lung function
- Any patient with uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
- Any patient with nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
- Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
- Patients receiving immunization with attenuated live vaccines during study participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify the maximum tolerated doses (MTD) of the combination of patupilone and RAD001
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
find toxicity of patupilone and RAD001, see if concentrations of RAD001 are elevated with patupilone, evaluate tumor response using standard imaging, develop pharmacodynamic markers that may predict/indicate response to mTOR inhibition or patupilone trt
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mark Stein, MD, Rutgers, the State University of New Jersey
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 050612
- CRAD001US16
- 0220060307 (Other Identifier: CINJ IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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