Non-Small Cell Lung CancerPhase 1NCT01212627
Ridaforolimus With Cetuximab: Adv Non-Small Cell Lung, Colorectal, Head & Neck Cancer
A Phase 1 study testing Ridaforolimus in people with Non-Small Cell Lung Cancer, run by Angela Taber MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Ridaforolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Apr 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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).
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- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
memorial Hospital of Rhode island
Pawtucket, Rhode Island, 02860
The Miriam Hospital
Providence, Rhode Island, 02906
About this study
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
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
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Ridaforolimus
- Keywords
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RidaforolimusDrug
Also called deforolimus
Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Ridaforolimus | Experimental | Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression Receives: Drug: Ridaforolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab
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
Measured: 1 year
Secondary outcomes (1)
Check the Tolerability, and Maximum Tolerated Dose (MTD) of Several Dosing Schedules of Oral Ridaforolimus.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionApr 2013
Why it stopped: Determination to stop enrollment made due to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angela Taber MD
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, Memorial Hospital of Rhode Island, Roger Williams Medical Center
- Responsible party
- Sponsor-investigator, Angela Taber MD, Brown University
- Investigators
- Angela Plette, MD, Principal investigator, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212627
- Sponsor's protocol ID
- BrUOG-Phase 1-233
- Status last verified
- Jan 2021
- First submitted
- 29 Sep 2010
- Last updated
- 16 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01212627
- Acronym / sponsor ID
- BrUOG-Phase 1-233
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Determination to stop enrollment made due to funding
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Angela Taber MDUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital, Memorial Hospital of Rhode Island, Roger Williams Medical Center
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Posted 25 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ridaforolimus | Experimental | Drug: RidaforolimusRidaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RidaforolimusAlso: deforolimusRidaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle | Drug | Ridaforolimus |
Primary outcome
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
1 secondary outcome
Check the Tolerability, and Maximum Tolerated Dose (MTD) of Several Dosing Schedules of Oral Ridaforolimus.
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Plette, MD principal investigator
Lifespan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ridaforolimus in people with Non-Small Cell Lung Cancer, run by Angela Taber MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.