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Oral Cavity CancerPhase 1/2NCT01116843

Study to Assess Biomarkers in Patients With Resectable Oral Cavity Cancer Randomized to Receive Preoperative Treatment

A Phase 1/2 study testing PF-00299804 in people with Oral Cavity Cancer, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess the biological effects in the primary tumor following a short, pre-operative course of treatment with PF-00298804 in patients with Oral Cavity Cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Cavity Cancer
What is being tested?
PF-00299804
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
1 siteCanada
Study dates
May 2010to Feb 2014
Phase
Phase 1/2
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

  • Signed, voluntary informed consent provided
  • Willing and able to comply with scheduled visits, treatment plan, tests, other study procedures
  • Patient must be diagnosed with histologically confirmed oral cavity squamous cell carcinoma (OCC) (lip, floor of mouth, anterior 2/3 tongue, buccal mucosa, upper and lower gingiva, hard palate and retromolar trigone) considered resectable (T1-4a, N0-2, M0; (without distant metastases)) for whom surgical resection of tumor is planned. Patients with distant metastatic disease or diagnosis of SCCHN may not be enrolled
  • Must be able to provide a fresh tumor biopsy prior to randomization for histopathological and biomarker evaluation. No anti-neoplastic treatment allowed between obtaining baseline tumor specimen and randomization. Patients who decline an in-house fresh pre-treatment tumor biopsy must give consent to provide a tumor block from an existing diagnostic primary tumor biopsy completed within 90 days of enrolment
  • Prior treatment with agents targeted to epidermal growth factor receptor is not allowed.
  • No prior chemotherapy or radiotherapy (to primary site/nodes).
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  • Patient must not have received prior anti-neoplastic treatment within past 2 years
  • Any treatment-related acute toxicity, including laboratory abnormalities, must have recovered to CTCAE Grade 1 (v.4.0) or baseline, except toxicity not considered a safety risk.
  • ECOG performance status of 0-2.
  • Patient must have adequate organ function as determined by the following criteria:
  • Serum creatinine ≤ 1.5 ULN or a calculated creatinine clearance of ≥ 50 mL/min
  • Absolute neutrophil count ≥ 1.5 x 109/L
  • Leukocytes > 3.0 x 109/L
  • Hemoglobin > 80 g/L
  • Platelets > 100 x 109/L
  • Total bilirubin < ULN
  • AST (SGOT) and ALT (SGPT) < 2.5 x ULN
  • 12-Lead ECG with normal tracing, or clinically non-significant changes that do not require medical intervention
  • QTc interval < 470 msec, and without history of Torsades de Pointes or other symptomatic QTc abnormality
  • A normal LVEF of >50% as measured by ECHO or MUGA within 4 weeks prior to start of study treatment will be required for all patients

Who cannot join

  • Patients who require segmental mandibulectomy for surgical resection of oral cavity tumor will not be enrolled
  • Primary site of head and neck carcinoma in nasopharynx, skin, or unknown
  • Prior or concurrent radiation therapy to tumor at site of planned resection
  • Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of PF-00299804
  • Requirement for treatment with drugs that are highly dependent on CYP2D6 for metabolism since PF-00299804 is a potent CYP2D6 inhibitor in in vitro assays
  • Patients currently taking drugs that have a risk of causing Torsades de Pointes
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  • Any acute or chronic medical, psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry in the trial
  • Other serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment as determined by investigator
  • Dementia or significantly altered mental status that would limit the ability to obtain informed consent and compliance with the requirements of this protocol
  • Patients breastfeeding or pregnant are excluded. All female patients with reproductive potential must have a negative pregnancy test within 72 hours prior to treatment.
  • Patients of reproductive potential or their partners must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter.
  • Current enrollment in another therapeutic clinical trial
  • Inability/lack of willingness to comply with visits, treatment plans, protocol assessments or laboratory tests

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Preoperative Window of Opportunity Study to Assess the Modulation of Biomarkers in the Primary Tumor Site of Patients With Resectable Oral Cavity Cancer (OCC) Randomized to Receive Preoperative Treatment With PF-00299804

The objective of this study is to assess the biological effects in the primary tumor following a short, pre-operative course of treatment with PF-00298804 in patients with Oral Cavity Cancer.

Read the detailed description

This is a single-center, randomized, double-blinded, biomarker driven, preoperative window of opportunity study with a pharmacodynamic primary endpoint. Patients with resectable, histologically confirmed OCC for whom surgical treatment is planned as definitive management, will be randomized 2:1 to receive PF-00299804 pre-operatively at a dose of 45 mg once daily orally for 7-11 days or to Matching Placebo for 7-11 days depending on surgery schedule. The target is a total of 8 days of treatment but with a minimum of 7 and a maximum of 11 dosing days. All patients will receive surgery as per standard of care without delay. Biomarkers from the surgical specimen and baseline tumor biopsy or consent to provide a tumor block from existing primary diagnostic tumor biopsy completed within 90 days will be evaluated for primary and secondary pharmacodynamic endpoints.

Being tested
PF-00299804
Keywords
Oral cavity cancer, No prior treatment
Medical subject headings
Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-00299804Drug

    Also called A7471001

    PF-00299804 or Placebo given pre-operatively for 7 to 11 days depending on surgery schedule.

Study groups in NCT01116843
Study groupRoleWhat they receive
PF-00299804ExperimentalPatient will receive PF-00299804 pre-operatively at a dose of 45 mg once daily orally for 7-11 days depending on surgery schedule.
Receives: Drug: PF-00299804
Placebo armPlacebo comparatorPatient will receive matching Placebo for 7-11 days depending on surgery schedule.
Receives: Drug: PF-00299804

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the degree of modulation of the proliferation index, ki-67, in the primary tumor of OCC specimens following a short, preoperative course of PF-00299804

    Measured: 8-11 months

Secondary outcomes (5)

  1. To evaluate changes in tissue and blood-based biomarkers before, during and after treatment with PF-00299804 and attempt to correlate with gene expression changes, EGFR variant III mutation status, EGFR amplification and histopathological changes

    Measured: 8-11 months

  2. To assess the relationship between pharmacokinetic parameters and molecular changes detected in OCC tumor specimens

    Measured: 8-11 months

  3. To assess the safety and tolerability of pre-operative PF-00299804

    Measured: 8-11 months

  4. To quantitatively assess the effect of PF-00299804 on tumorigenic cells expressing CD44+/Lin- markers in paired OCC tumor specimens

    Measured: 8-11 months

  5. To evaluate gene expression changes in tumor tissue before and after treatment with PF00299804

    Measured: 8-11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionFeb 2012
  4. Study completionFeb 2014

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01116843
Sponsor's protocol ID
WS590266
Status last verified
Jul 2015
First submitted
3 May 2010
Last updated
10 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PF-00299804 in people with Oral Cavity Cancer, run by University Health Network, Toronto at 1 site in Canada.

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 20 inclusion and 13 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 10 Jul 2015. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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?

To assess the degree of modulation of the proliferation index, ki-67, in the primary tumor of OCC specimens following a short, preoperative course of PF-00299804 (time frame: 8-11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01116843.

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 10 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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