Esophageal Squamous Cell CarcinomaPhase 2NCT01608022
A Phase II Trial of PF-00299804 in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus
A Phase 2 study testing PF804 in people with Esophageal Squamous Cell Carcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Esophageal cancer (EC) is the eighth most common cause of cancer-related death in the worldwide. Systemic chemotherapy in patients with metastatic EC has limited effectiveness, resulting in a median survival of 8 months to 10months. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- PF804
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Oct 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed squamous cell carcinoma of esophagus
- Age >= 18
- ECOG PS 0-2
- Ineligibility for local therapy (surgery or radiotherapy)
- Not more than one prior palliative therapy
- At least one bidimensionally measurable disease as defined by RECIST ver 1.1
Show all 17Show fewer
- Adequate organ function for treatment
- Absolute neutrophil count (ANC)>=1000cells/mm3
- Platelets >=100000 cells/mm3
- Estimated creatinine clearance>=50mL/min, or serum creatinine<1.5 x institution upper limit of normal
- Bilirubin=<1.5 x upper limit of normal(ULN)
- AST(SGOT)=<2.5 x ULN (5.0xULN if hepatic metastases)
- ALT(SGPT)=<2.5 x ULN (5.0xULN if hepatic metastases)
- 12-Lead electrocardiogram(ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
- QTc interval =<470 msec and without history of Torsades de Points or other symptomatic QTc abnormality
- LVEF (by MUGA or echocardiogram) of >=50%.
- The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.
Who cannot join
- Previous treatment with small molecule EGFR tyrosine kinase inhibitors
- Two or more previous systemic cytotoxic chemotherapy (Chemotherapy administered with concurrent radiotherapy for local control is not counted)
- 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
- CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
- Patients with known interstitial lung disease
Show all 10Show fewer
- 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)
- Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry.
- 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
1 site in 1 country.
About this study
Esophageal cancer (EC) is the eighth most common cause of cancer-related death in the worldwide. Systemic chemotherapy in patients with metastatic EC has limited effectiveness, resulting in a median survival of 8 months to 10months. The low activity and brief duration of benefit for chemotherapy to palliate advanced disease make clear need to identify new active agents.
Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with EC. The association between EGFR-activated signaling pathways and tumor cell survival are well documented in many studies. Some EGFR tyrosine kinase inhibitors (TKIs) already showed clinical efficacy against EC. A study with erlotinib showed objective response rate of 15% (2 of 13 patients), but activity was limited to squamous cell type.8 In another study, thirty patients with malignant solid tumor were treated with BIBW2992, irreversible inhibitor of EGFR and HER2, and one of four EC patients achieved partial response.
Read more
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. PF-00299804 reportedly have clinical anti-tumor activity in patients with non-small cell lung cancer and head and neck squamous cell carcinoma with manageable toxicity.
The aim of current trial is to evaluate the antitumor efficacy and safety profile of PF-00299804 and to identify biomarker to predict the tumor response to PF-00299804.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- PF804
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF804Drug
45 mg p.o. daily and continuously (28-day treatment as one treatment cycle)
| Study group | Role | What they receive |
|---|---|---|
| PF804 | Experimental | Not described Receives: Drug: PF804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Objective Tumor Response will be performed according to the Response Evaluation in Solid Tumor Criteria (RECIST).
Measured: 28th day of every chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608022
- Sponsor's protocol ID
- 4-2012-0014
- Status last verified
- Sep 2016
- First submitted
- 18 May 2012
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of PF-00299804 in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus
- ClinicalTrials.gov ID
- NCT01608022
- Acronym / sponsor ID
- 4-2012-0014
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 May 2012 (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.
Esophageal cancer (EC) is the eighth most common cause of cancer-related death in the worldwide. Systemic chemotherapy in patients with metastatic EC has limited effectiveness, resulting in a median survival of 8 months to 10months. The low activity and brief duration of benefit for chemotherapy to palliate advanced disease make clear need to identify new active agents.
Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with EC. The association between EGFR-activated signaling pathways and tumor cell survival are well documented in many studies. Some EGFR tyrosine kinase inhibitors (TKIs) already showed clinical efficacy against EC. A study with erlotinib showed objective response rate of 15% (2 of 13 patients), but activity was limited to squamous cell type.8 In another study, thirty patients with malignant solid tumor were treated with BIBW2992, irreversible inhibitor of EGFR and HER2, and one of four EC patients achieved partial response.
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. PF-00299804 reportedly have clinical anti-tumor activity in patients with non-small cell lung cancer and head and neck squamous cell carcinoma with manageable toxicity.
The aim of current trial is to evaluate the antitumor efficacy and safety profile of PF-00299804 and to identify biomarker to predict the tumor response to PF-00299804.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF804 | Experimental | Drug: PF804 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed squamous cell carcinoma of esophagus
- Age >= 18
- ECOG PS 0-2
- Ineligibility for local therapy (surgery or radiotherapy)
- Not more than one prior palliative therapy
Key exclusion criteria (10 listed)
- Previous treatment with small molecule EGFR tyrosine kinase inhibitors
- Two or more previous systemic cytotoxic chemotherapy (Chemotherapy administered with concurrent radiotherapy for local control is not counted)
- 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
- CNS metastasis with continuous corticosteroid use 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 |
|---|---|---|
| PF80445 mg p.o. daily and continuously (28-day treatment as one treatment cycle) | Drug | PF804 |
Primary outcome
Overall Response Rate
Time frame: 28th day of every chemotherapy cycle
Objective Tumor Response will be performed according to the Response Evaluation in Solid Tumor Criteria (RECIST).
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 7 Sep 2016.
Related trials for Esophageal Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF804 in people with Esophageal Squamous Cell Carcinoma, run by Yonsei University at 1 site 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 17 inclusion and 10 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 7 Sep 2016. 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 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?
Overall Response Rate (time frame: 28th day of every chemotherapy cycle). 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 7 Sep 2016.