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Phase I Study of Patupilone and RAD001 in Patients With Refractory Solid Tumor Malignancy

Phase 1
18 Years
Not Enrolling
Refractory Malignancy

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Trial Information

Phase I Study of Patupilone and RAD001 in Patients With Refractory Solid Tumor Malignancy

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.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To identify the maximum tolerated doses (MTD) of the combination of patupilone and RAD001

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Mark Stein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey


United States: Institutional Review Board

Study ID:




Start Date:

July 2007

Completion Date:

February 2011

Related Keywords:

  • Refractory Malignancy
  • Neoplasms



The Cancer Institute of New Jersey New Brunswick, New Jersey  08901