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Malignant Pleural MesotheliomaPhase 2NCT01486368

A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma

A Phase 2 study testing PF-03446962 in people with Malignant Pleural Mesothelioma, run by NCIC Clinical Trials Group at 7 sites 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

This is a non-randomized open label multicentre Phase II trial to evaluate the response rate of PF03446962 in patients with advanced malignant pleural mesothelioma who have been previously treated with cytotoxic chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Pleural Mesothelioma
What is being tested?
PF-03446962
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
7 sitesCanada
Study dates
26 Jun 2012to 13 Feb 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed malignant pleural mesothelioma.
  • Patients must have advanced and/or metastatic disease, incurable by standard therapies.
  • All patients must have a tumour block from their primary or metastatic tumour available and consent to release the block for correlative analyses. Centre/pathologist must have agreed to the submission of the specimens in both Stage I and II of accrual. For patients entered in Stage I of accrual, if no archival tissue is available, patient must undergo a biopsy prior to registration.
  • All patients entered in Stage II of accrual must have an accessible tumour lesion (from primary or metastatic disease) for a fresh biopsy, which is formalin fixed and paraffin embedded. These patients must consent to this biopsy for entry on the trial.
  • Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows:
  • Chest X-ray ≥ 20 mm CT scan (with slice thickness of ≤ 5 mm) ≥ 10 mm longest diameter Physical exam (using calipers) ≥ 10 mm Lymph nodes by CT scan ≥ 15 mm measured in short axis All radiology studies must be performed within 21 days prior to registration (Exception: Within 28 days if negative).
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  • Age ≥ 18 years.
  • Patients must have a life expectancy of at least 12 weeks.
  • ECOG performance status 0 or 1. Performance Status 2 patients are eligible, if, in the opinion of the investigator, they are suitable for inclusion in the study and are likely to be compliant with the study procedures (in particular the recommendations for supportive care and dose modification).
  • Previous Therapy
  • Cytotoxic Chemotherapy:
  • Patients are eligible after first line cytotoxic chemotherapy has failed
  • Patients must have received one, but no more than one, combination chemotherapy regimen for advanced disease, which must have contained a platinum agent, and treatment failure must have been documented
  • o Exchange of one chemotherapy agent for another within a combination chemotherapy regimen due to toxicity (and not due to progressive disease) is not considered a new regimen in the following circumstances
  • Carboplatin is substituted for cisplatin due to nephrotoxicity or ototoxicity
  • One agent in the combination regimen is changed due to hypersensitivity occurring in the first cycle
  • 28 days must have elapsed since last chemotherapy treatment (at least 6 weeks for nitrosoureas or mitomycin C) and patient must have recovered from toxic effects.
  • Other Anti-Cancer Therapy:
  • Patients may have received other non-cytotoxic investigational therapy; 28 days must have elapsed since last treatment, such as anti-angiogenic or growth factor antagonists.
  • Radiation:
  • Patients may have had prior radiation therapy. A minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study. Radiation must have involved < 30% of functioning bone marrow and there must be measurable disease outside the previously irradiated area (patients whose sole site of disease is in previously irradiated area are ineligible) unless there is evidence of progression or new lesions have been documented, in the irradiated field). [Exceptions may be made however for low dose palliative radiotherapy].
  • Previous Surgery:
  • Previous major surgery is permitted provided that it has been at least 28 days prior to patient registration and that wound healing has occurred.
  • Laboratory requirements must be done within 7 days prior to registration) Hematology: Granulocytes (ANC) ≥1.5 x 109/L Platelets ≥100 x 109/L Chemistry: Bilirubin ≤ULN AST and ALT ≤2.5 x ULN Calcium ≤3 mmol /L INR ≤1.5 x ULN Serum creatinine ≤ULN Or Creatinine clearance ≥60 ml/min if creatinine is >ULN Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula:Females: GFR=1.04 x(140-age)x weight in kg serum creatinine in μmol/L; Males: GFR=1.23 x (140-age)x weight in kg serum creatinine in μmol/L
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to registration in the trial to document their willingness to participate.
  • Patients must be accessible for treatment, response assessment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, response assessment, adverse events and follow up.
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration.

Who cannot join

  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥5 years.
  • Patients with known brain metastases. (A head CT is not necessary to rule out brain metastases, unless there is clinical suspicion of CNS involvement). Patients with known brain metastases will be excluded from this trial due to their poor prognosis and their likelihood of developing progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PF-03446962.
  • Patients receiving concurrent treatment with other anti-cancer therapy or other investigational anticancer agents.
  • Patients with any of the following cardiovascular findings are to be excluded:
  • QTc prolongation ( defined as a mean QTc interval with Bazetts correction equal to or greater than 470 msec) in screening ECG or history of familial long QT syndrome. An ECG must be done within 14 days prior to registration.
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  • Patients with resting BP consistently higher than, systolic > 150 mmHg and/or diastolic > 100 mmHg (in the presence or absence of a stable dose of anti-hypertensive medication) or poorly controlled hypertension, history of labile hypertension or poor compliance with anti-hypertensive medication.
  • Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history even if controlled, should have a LVEF > 50%.
  • History of pulmonary embolism within the past 12 months; exceptions may be made for incidental pulmonary emboli found on routine scanning providing not within the past 6 months.
  • History of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry.
  • Patients with overt bleeding from any site (> 30 ml bleeding/episode) within 3 months of study entry are not eligible. No clinically relevant hemoptysis (> 5 ml fresh blood) within 4 weeks prior to study entry is permitted. Patients with only flecks of blood in sputum are permitted.
  • Patients who require use of therapeutic doses of anticoagulants such as warfarin, heparin or low molecular weight heparin (except for low doses for prophylaxis). INR must be done within 7 days prior to registration.
  • Patients with bowel obstruction or any condition or gastrointestinal tract disease that would increase the risk for gastrointestinal perforation, including abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
  • Patients with serious illness or medical condition which would not permit the patient to be managed according to the protocol including, but not limited to:
  • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements;
  • Active uncontrolled infection;
  • Any other medical conditions that might be aggravated by treatment;
  • Serious or non-healing wound, ulcer, or bone fracture.
  • The following are exclusions for enrollment on the study:
  • Pregnant or lactating women. (N.B.: All women of childbearing potential must have a negative pregnancy test within 7 days prior to registration).
  • Women must be post-menopausal, surgically sterile or use two reliable forms of contraception while on study and for 6 months after discontinuing therapy. Men must be surgically sterile or use a barrier method of contraception with spermicide. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Ottawa Health Research Institute - General Division

    Ottawa, Ontario, K1H 8L6

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

This is a non-randomized open label multicentre Phase II trial to evaluate the response rate of PF03446962 in patients with advanced malignant pleural mesothelioma who have been previously treated with cytotoxic chemotherapy.

Read the detailed description

To assess the efficacy (response rate, complete and partial) of PF-03446962 given by IV infusion Day 1 of a 2 week cycle (14 days = 1 cycle) in patients with advanced malignant pleural mesothelioma and previously treated with cytotoxic therapy.

To assess the toxicity, safety and tolerability of PF-03446962.

To assess the duration of response or stable disease, stable disease rate, progression-free, median and overall survival rates.

To collect tissue and blood for banking and correlative science evaluation.

Being tested
PF-03446962
Medical subject headings
Mesothelioma, Malignant

What participants receive

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

  • PF-03446962Drug

    PF-03446962 will be administered by IV infusion every 2 weeks (q2w). A cycle will be 2 weeks in duration and include one administration of PF-03446962.

Study groups in NCT01486368
Study groupRoleWhat they receive
PF-03446962ExperimentalNot described
Receives: Drug: PF-03446962

What is being measured

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

  1. Response Rate

    Assessing the efficacy (response rate, complete and partial) of PF-03446962 given by IV infusion Day 1 of a 2 week cycle(14 days = 1 cycle) in patients with malignant pleural mesothelioma and previously treated with cytotoxic therapy.

    Measured: 30 months

Secondary outcomes (3)

  1. Amount and severity of adverse events

    To assess toxicity, safety and tolerability of PF-03446962.

    Measured: 30 months

  2. Duration of Response

    To assess the duration of response or stable disease, stable disease rate, progression-free survival, median and overall survival rates

    Measured: 30 months

  3. Blood and tissue marker evaluation

    Specimen collection to look for markers in cancer cells. These markers might help predict which patients are most likely to be helped by the study drug PF-03446962.

    Measured: 30 months

Timeline

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

  1. First posted6 Dec 2011 (estimated)
  2. Study start26 Jun 2012
  3. Primary completion27 Apr 2014
  4. Study completion13 Feb 2015

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01486368
Sponsor's protocol ID
I207
Status last verified
Apr 2020
First submitted
1 Dec 2011
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wheatley-Price P, Chu Q, Bonomi M, Seely J, Gupta A, Goss G, Hilton J, Feld R, Lee CW, Goffin JR, Maksymiuk A, Murray N, Hagerman L, Bradbury PA. A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma. CCTG Trial IND.207. J Thorac Oncol. 2016 Nov;11(11):2018-2021. doi: 10.1016/j.jtho.2016.06.024. Epub 2016 Jul 20.

    PubMed 27449804

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-03446962 in people with Malignant Pleural Mesothelioma, run by NCIC Clinical Trials Group at 7 sites 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 27 inclusion and 21 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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. 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: 30 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 NCT01486368, which also lists 1 linked publication.

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 4 Aug 2023.

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