Head Neck Cancer Squamous Cell MetastaticPhase 2NCT01449201
PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing PF-00299804 in people with Head Neck Cancer Squamous Cell Metastatic and Head Neck Cancer Squamous Cell Recurrent, run by Yonsei University at 6 sites in South Korea.
Trial summary
Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Neck Cancer Squamous Cell Metastatic, Head Neck Cancer Squamous Cell Recurrent
- What is being tested?
- PF-00299804
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Oct 2011to Mar 2014
- Phase
- Phase 2
- 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 confirmed squamous cell carcinoma of head and neck
- Age ≥ 18
- ECOG PS 0-2
- Documented progressive disease after platinum-based systemic chemotherapy (either cisplatin or carboplatin) with or without cetuximab
- At least one bidimensionally measurable disease
- Adequate organ function for treatment
- Availability of tumor tissue for molecular analysis (archival or rebiopsy tissue)
Who cannot join
- Nasopharyngeal carcinoma
- Eligibility for local therapy (surgery or radiotherapy)
- Previous treatment with small molecule EGFR tyrosine kinase inhibitors
- More than one systemic chemotherapy
- Any major operation or irradiation within 4 weeks of baseline disease assessment
- Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
Show all 12Show fewer
- CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
- Patients with known interstitial lung disease
- Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months, Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
- Concomitant malignancy (except adequately treated basal cell cancer of skin or cervical cancer in situ)
- Pregnant or breast-feeding women
- Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Chilgok Kyungpook National University Hospital
Daegu
Dongsan Medical Center
Daegu
Severance Hospital
Seoul, Seoul, 120-752
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital Cancer Center
Seoul
About this study
Official title: Phase II Trial of PF-00299804 in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy
Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. In preclinical studies, PF-00299804 has much lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations (1.2 nM versus 2,700 nM) and produces tumor growth inhibition in gefitinib-resistant xenografts. A phase II trial of PF-00299804 in patients with recurrent or metastatic HNSCC is currently ongoing and preliminary report in ASCO 2010 showed its anti-tumor activity against HNSCC. The investigators suggest a phase II trial of pan-HER inhibitor PF-00299804 in patients with recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.
- Being tested
- PF-00299804
- Keywords
- PF-00299804, head and neck cancer, squamous cell carcinoma
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-00299804Drug
45 mg P.O. Daily (28-day treatment as one treatment cycle)
| Study group | Role | What they receive |
|---|---|---|
| PF-00299804 | Experimental | Not described Receives: Drug: PF-00299804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression
Measured: every 8 weeks
Secondary outcomes (4)
Best objective response
Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression
Measured: every 8 weeks
Progression-free survival
from C1D1 until confirmed disease progression or death
Measured: every 8 weeks
Overall survival
from C1D1 to death
Measured: every 12 weeks
Toxicity profile
from C1D1 to 1 months after the last dose adminitration
Measured: every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Neck Cancer Squamous Cell MetastaticStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byoung Chul Cho, Yonsei University
- Investigators
- Byoung Chul Cho, M.D.,Ph.D., Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449201
- Sponsor's protocol ID
- 4-2011-0434
- Status last verified
- Sep 2014
- First submitted
- 4 Oct 2011
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of PF-00299804 in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy
- ClinicalTrials.gov ID
- NCT01449201
- Acronym / sponsor ID
- 4-2011-0434
- Keywords
- PF-00299804, head and neck cancer, squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Oct 2011 (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.
Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. In preclinical studies, PF-00299804 has much lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations (1.2 nM versus 2,700 nM) and produces tumor growth inhibition in gefitinib-resistant xenografts. A phase II trial of PF-00299804 in patients with recurrent or metastatic HNSCC is currently ongoing and preliminary report in ASCO 2010 showed its anti-tumor activity against HNSCC. The investigators suggest a phase II trial of pan-HER inhibitor PF-00299804 in patients with recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-00299804 | Experimental | Drug: PF-00299804 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed squamous cell carcinoma of head and neck
- Age ≥ 18
- ECOG PS 0-2
- Documented progressive disease after platinum-based systemic chemotherapy (either cisplatin or carboplatin) with or without cetuximab
- At least one bidimensionally measurable disease
Key exclusion criteria (12 listed)
- Nasopharyngeal carcinoma
- Eligibility for local therapy (surgery or radiotherapy)
- Previous treatment with small molecule EGFR tyrosine kinase inhibitors
- More than one systemic chemotherapy
- Any major operation or irradiation within 4 weeks of baseline disease assessment
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 |
|---|---|---|
| PF-0029980445 mg P.O. Daily (28-day treatment as one treatment cycle) | Drug | PF-00299804 |
Primary outcome
Response rate
Time frame: every 8 weeks
Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression
4 secondary outcomes
Best objective response
Time frame: every 8 weeks
Progression-free survival
Time frame: every 8 weeks
Overall survival
Time frame: every 12 weeks
Toxicity profile
Time frame: every 4 weeks
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 30 Sep 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.
Byoung Chul Cho, M.D.,Ph.D. principal investigator
Yonsei University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00299804 in people with Head Neck Cancer Squamous Cell Metastatic and Head Neck Cancer Squamous Cell Recurrent, run by Yonsei University at 6 sites in South Korea.
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 7 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: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response rate (time frame: every 8 weeks). 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 30 Sep 2014.