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Ridaforolimus With Cetuximab: Adv Non-Small Cell Lung, Colorectal, Head & Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212627
Recruitment Status : Terminated (Determination to stop enrollment made due to funding)
First Posted : September 30, 2010
Results First Posted : June 25, 2015
Last Update Posted : February 16, 2021
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Information provided by (Responsible Party):
Angela Taber MD, Brown University

Brief Summary:
The main purpose of this study is to evaluate the best dose, safety and side effects of ridaforolimus when given with cetuximab for patients with head and neck, lung and colon cancer that has progressed after initial therapy. A second purpose of this study is to gain preliminary information on whether the combination of ridaforolimus and cetuximab is helpful in treating patients with advanced head and neck cancer

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Ridaforolimus Phase 1

Detailed Description:
Patients with advanced NSCLC, colorectal cancer, and head and neck cancer that progressed after at least 1 prior regimen for metastatic disease were eligible. Wild-type K-ras was required in colon cancer. All patients received cetuximab 400 mg/m2 week 1 followed by 250 mg/m2/week. Four dose levels of ridaforolimus were planned: 10mg, 20mg, 30mg, and 40mg daily, 5 days each week, on a 28-day cycle.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Ridaforolimus
Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
Drug: Ridaforolimus
Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
Other Name: deforolimus

Primary Outcome Measures :
  1. Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab [ Time Frame: 1 year ]

    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

    Weekly Ridaforolimus Dose Level 1 20 mg/day Dose Level 2 30 mg/day Dose Level 3 40 mg/day

Secondary Outcome Measures :
  1. Check the Tolerability, and Maximum Tolerated Dose (MTD) of Several Dosing Schedules of Oral Ridaforolimus. [ Time Frame: 1 year ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 treatment.
  • 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 contraception
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01212627

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United States, Rhode Island
memorial Hospital of Rhode island
Pawtucket, Rhode Island, United States, 02860
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Angela Taber MD
Rhode Island Hospital
The Miriam Hospital
Memorial Hospital of Rhode Island
Roger Williams Medical Center
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Principal Investigator: Angela Plette, MD Lifespan
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Responsible Party: Angela Taber MD, Principle Investigator, Brown University Identifier: NCT01212627    
Other Study ID Numbers: BrUOG-Phase 1-233
First Posted: September 30, 2010    Key Record Dates
Results First Posted: June 25, 2015
Last Update Posted: February 16, 2021
Last Verified: January 2021
Keywords provided by Angela Taber MD, Brown University:
Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms