Recurrent Head and Neck CancerPhase 1NCT01255800
Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer
A Phase 1 study testing IPI-926 and Cetuximab in people with Recurrent Head and Neck Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926 in combination with cetuximab in patients with advanced head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Cancer
- What is being tested?
- IPI-926 and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 confirmed advanced or metastatic head and neck squamous cell (HNSCC) cancer not amenable to potentially curative resection.
- Tumor must be amenable to sequential biopsies, and patients must be willing to undergo 3 sequential tumor biopsies.
- evidence of progression after first-line chemotherapy for locally advanced or recurrent disease. There has to be at least a 4-week period since the last administration of prior therapy and initiation of the current study drugs.
- Cetuximab is indicated. However, prior therapy with cetuximab (particularly if in the primary setting) is allowed.
- Presence of measurable target on a CT-scan available for external review, with at least one diameter >/= 2cm (>/= 1cm if spiral CT-scan is used for assessment and follow-up).
- Age >/= 18 years.
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- The Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%, see Appendix A).
- Life expectancy greater than 12 weeks.
- Patients must have normal organ and marrow function as defined below:
- leukocytes >3,000/μl
- absolute neutrophil count >1,500/μl
- platelets >100,000/μl
- total bilirubin <1.5x Upper limit normal (ULN)
- Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) <2.5 X institutional upper limit of normal
- creatinine <1.5x ULN OR
- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine above ULN.
- All women of child-bearing potential (WCBP),all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study. Women of child-bearing potential (defined as being less than 1 year post-menopausal) must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy while receiving study drug and for 30 days after the final dose of study drug.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients receiving any other investigational agents.
- Patients with known brain metastases.
- History of allergic reactions attributed to cetuximab or compounds of similar chemical or biologic composition to IPI-926.
- Patients taking rifampin, St. John's wort, carbamazepine, phenytoin, and phenobarbital are excluded from this trial.
- Uncontrolled illness including, hypertension, ongoing or active infection, bleeding diathesis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Baseline Fridericia's formula (QTcF) >450 msec in men or >470 msec in women.
- Concurrent treatment with any agent known to prolong the Corrected QT (QTc) interval
- Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and meet any of the following criteria are excluded:
- Have been on a stable dose of anticoagulation for <1 month
- Have had a Grade 2, 3 or 4 hemorrhage in the past month
- Are experiencing continued symptoms from their venous thromboembolic event Patients who have had a venous thromboembolic event but do not meet any of the above three criteria are eligible for participation.
- History of a seizure within the last 10 years or seizure disorder requiring anti-epileptic medications.
- Known HIV-positive patients.
- Therefore, patients taking potent inhibitors or inducers of Cytochrome P450 3A4 (CYP 3A4) should not be enrolled on this study.
- active infection or systemic use of antibiotic within 72 hours of treatment
- Cirrhotic liver disease, ongoing alcohol abuse, or chronic active or acute hepatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Denver, Colorado, 80045
About this study
Official title: A Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer: a Rational Anti-Cancer Stem Cell Combination.
This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926 in combination with cetuximab in patients with advanced head and neck cancer.
Read the detailed description
The purpose of this study is to determine the dose-limiting toxicities and the recommended dose for phase 2 evaluation of the combination of IPI-926 and cetuximab in patients with advanced head and neck cancer.
- Conditions
- Recurrent Head and Neck Cancer
- Being tested
- IPI-926 and Cetuximab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-926 and CetuximabDrug
Also called brand name: ERBITUX
- Patients will receive Cetuximab IV every week.
- Starting on Day 15 of the first cycle, Patients will take IPI-926by mouth every day.
| Study group | Role | What they receive |
|---|---|---|
| IPI-926 and Cetuximab | Experimental | * Patients will receive Cetuximab IV every week.
* Starting on Day 15 of the first cycle, Patients will take the study drug by mouth every day. Receives: Drug: IPI-926 and Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities and the recommended dose for phase 2 evaluation of the combination of IPI-926 and cetuximab
Cohorts of 3. The first cohort will receive dose level 1. A full safety evaluation will be conducted after 6 weeks. If 0/3 have a Dose limiting toxicity (DLT), then a new cohort will receive the next dose level. If 1/3 have DLT then 3 more patients will be treated at this dose level. If none has DLT then the next dose level will be administered to the next cohort; otherwise the inferior dose level will be considered the maximum tolerated dose (MTD). If 2/3 have a DLT, then the inferior dose level will be considered the MTD. In the event that the initial dose level 1 is not tolerated, a level -1 has been defined for assessment.
Measured: The first 3 patients enrolled will receive the first dose level. A full safety evaluation will be conducted after 6 weeks of therapy. This will continue until a MTD is determined.
Secondary outcomes (1)
Evaluate the clinical activity of the combination of IPI-926 with cetuximab
Obtaining tumor biopsies at baseline, after 2 weeks of cetuximab, and after 3-4 weeks of dual therapy will enable testing our hypotheses. Patients will be assessed by standard criteria. CTs will also be conducted at the end of first cycle to assess disease progression. Confirmatory scans will also be obtained 4 weeks following initial documentation of an objective response. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [The Journal of the National Cancer Institute (JNCI) 92(3):205-216, 2000].
Measured: Patients will continue to receive treatment as long as there is evidence that their tumor is not growing and they are not experiencing any unacceptable side effects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Jimeno, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255800
- Sponsor's protocol ID
- 11-0109.cc
- Status last verified
- Jan 2014
- First submitted
- 6 Dec 2010
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer: a Rational Anti-Cancer Stem Cell Combination.
- ClinicalTrials.gov ID
- NCT01255800
- Acronym / sponsor ID
- 11-0109.cc
- Conditions
- Recurrent Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926 in combination with cetuximab in patients with advanced head and neck cancer.
Detailed description
The purpose of this study is to determine the dose-limiting toxicities and the recommended dose for phase 2 evaluation of the combination of IPI-926 and cetuximab in patients with advanced head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPI-926 and Cetuximab | Experimental | Drug: IPI-926 and Cetuximab* Patients will receive Cetuximab IV every week. * Starting on Day 15 of the first cycle, Patients will take the study drug by mouth every day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- histologically or cytologically confirmed advanced or metastatic head and neck squamous cell (HNSCC) cancer not amenable to potentially curative resection.
- Tumor must be amenable to sequential biopsies, and patients must be willing to undergo 3 sequential tumor biopsies.
- evidence of progression after first-line chemotherapy for locally advanced or recurrent disease. There has to be at least a 4-week period since the last administration of prior therapy and initiation of the current study drugs.
- Cetuximab is indicated. However, prior therapy with cetuximab (particularly if in the primary setting) is allowed.
- Presence of measurable target on a CT-scan available for external review, with at least one diameter >/= 2cm (>/= 1cm if spiral CT-scan is used for assessment and follow-up).
Key exclusion criteria (17 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients receiving any other investigational agents.
- Patients with known brain metastases.
- History of allergic reactions attributed to cetuximab or compounds of similar chemical or biologic composition to IPI-926.
- Patients taking rifampin, St. John's wort, carbamazepine, phenytoin, and phenobarbital are excluded from this trial.
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 |
|---|---|---|
| IPI-926 and CetuximabAlso: brand name: ERBITUX* Patients will receive Cetuximab IV every week. * Starting on Day 15 of the first cycle, Patients will take IPI-926by mouth every day. | Drug | IPI-926 and Cetuximab |
Primary outcome
Dose-limiting toxicities and the recommended dose for phase 2 evaluation of the combination of IPI-926 and cetuximab
Time frame: The first 3 patients enrolled will receive the first dose level. A full safety evaluation will be conducted after 6 weeks of therapy. This will continue until a MTD is determined.
Cohorts of 3. The first cohort will receive dose level 1. A full safety evaluation will be conducted after 6 weeks. If 0/3 have a Dose limiting toxicity (DLT), then a new cohort will receive the next dose level. If 1/3 have DLT then 3 more patients will be treated at this dose level. If none has DLT then the next dose level will be administered to the next cohort; otherwise the inferior dose level will be considered the maximum tolerated dose (MTD). If 2/3 have a DLT, then the inferior dose level will be considered the MTD. In the event that the initial dose level 1 is not tolerated, a level -1 has been defined for assessment.
1 secondary outcome
Evaluate the clinical activity of the combination of IPI-926 with cetuximab
Time frame: Patients will continue to receive treatment as long as there is evidence that their tumor is not growing and they are not experiencing any unacceptable side effects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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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.
Antonio Jimeno, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPI-926 and Cetuximab in people with Recurrent Head and Neck Cancer, run by University of Colorado, Denver at 1 site 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 17 inclusion and 17 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: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose-limiting toxicities and the recommended dose for phase 2 evaluation of the combination of IPI-926 and cetuximab (time frame: The first 3 patients enrolled will receive the first dose level. A full safety evaluation will be conducted after 6 weeks of therapy. This will continue until a MTD is determined.). 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 31 Jan 2014.