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BrUOG- Phase 1-233: A Phase I Study of Ridaforolimus With Cetuximab for Patients With Advanced Head and Neck Cancer, Non-Small Cell Lung Cancer and Colon Cancer

Phase 1
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

Thank you

Trial Information

BrUOG- Phase 1-233: A Phase I Study of Ridaforolimus With Cetuximab for Patients With Advanced Head and Neck Cancer, Non-Small Cell Lung Cancer and Colon Cancer

Inclusion Criteria

Inclusion Criteria

- Histologically or cytologically advanced head and neck cancer, NSCLC or colorectal
cancer (wild-type KRAS) in whom there is no curable option and have progressed after
at least one regimen for advanced disease. Once the final dose level has been
determined, only patients with advanced lung cancer who fail at least one line of
chemotherapy will be eligible to be accrued to the 13 patient expanded cohort. *** As
of July 7, 2011 the final dosing level has been determined and the next cohort of
patients with advanced lung cancer will be enrolled**

- Patient has measurable disease by protocol-specific RECIST criteria.

- A minimum of 4 weeks has elapsed between prior chemotherapy and day 1 of study

- A minimum of 14 days has elapsed since prior kinase inhibitor therapy or
radiotherapy, and a minimum of 4 weeks has elapsed since prior bevacizumab.

- No prior exposure to an mTOR inhibitor. Prior cetuximab exposure is allowed.

- ECOG performance status 0-1

- Required initial lab values: Hemoglobin ≥9.0 g/dL, absolute neutrophil count
≥1,500/mm3, platelet count ≥100,000/mm3, total bilirubin ≤1.5 times the upper limit
of normal, AST or ALT <3 times the upper limit of normal, serum albumin ≥2.5 g/dL,
serum cholesterol ≤350 mg/dL, triglycerides ≤400 mg/dL, creatinine <1.5 times the
upper limit of normal, or a calculated creatinine clearance ≥50 ml/min.

- Age ≥18 years

- Those of child-bearing potential must agree to use of effective method of

- Patients must have the ability to understand and give written informed consent

Exclusion criteria:

- Patient is known to have active brain metastases. Patients with previously treated
brain metastases that are stable for >3months are eligible if a current brain MRI
(within 28 days of day 1 of study treatment) shows no edema or evidence of
progression compared to a prior study at least 3 months ago.

- Patient is currently participating or has participated in a study with an
investigational anticancer treatment or device within 30 days or 5 half lives of the
investigational compound (whichever is greater) of initial dosing with study drug.

- Patient has previously received rapamycin or rapamycin analogs, including
ridaforolimus, everolimus, or temsirolimus.

- Patient is receiving corticosteroids administered at doses greater than those used
for normal replacement therapy.

- Patient has a history of prior invasive malignancy except for basal cell carcinoma of
the skin within the past two years or who is deemed at low risk for recurrence by his
treating physician.

- Patient has known severe hypersensitivity to macrolide antibiotics (ie:
clarithromycin, erythromycin, or azythromycin).

- Patient has NYHA Class III or IV congestive heart failure or any other significant
history of cardiac disease including: myocardial infarction within the last 6
months; ventricular arrhythmia or acute congestive heart failure within the last 3
months; uncontrolled angina or uncontrolled hypertension.

- Patient is known to be HIV positive or has a known history of Hepatitis B or C.

- Patient has a psychiatric disorder that would interfere with cooperation with the
requirements of the trial, is a regular user of illicit drugs (including
"recreational use"), or has a recent history (within the last year) of drug or
alcohol dependence.

- Patient is pregnant or breastfeeding, or expecting to conceive within the projected
duration of the study.

- Patient has an active infection requiring intravenous antibiotics.

- Patient has a requirement for concurrent treatment with medications that are strong
inducers or inhibitors of cytochrome P450 (CYP3A) (see Appendix). Patients should
discontinue these medications for at least 2 weeks prior to the first dose of
ridaforolimus. Concomitant medications that are metabolized by CYP3A are allowed
(e.g., simvastatin or atorvastatin)

Type of Study:


Study Design:

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

Outcome Measure:

assess the safety, of several dosing schedules of oral ridaforolimus.

Outcome Description:

the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Angela Plette, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:

BrUOG-Phase 1-233



Start Date:

September 2010

Completion Date:

April 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • Colonic Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Head and Neck Neoplasms
  • Lung Neoplasms



Memorial Hospital of Rhode IslandPawtucket, Rhode Island  02860
The Miriam HospitalProvidence, Rhode Island  02903