A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma
NCT01486368
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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).
- 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.
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Edmonton, Alberta
- Surrey, British Columbia
- Vancouver, British Columbia
- Winnipeg, Manitoba
- Hamilton, Ontario
- Ottawa, Ontario
- Toronto, Ontario
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma | ||||||
Official Title ICMJE | A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma | ||||||
Brief 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. | ||||||
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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Malignant Pleural Mesothelioma | ||||||
Intervention ICMJE | Drug: PF-03446962
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 Arms ICMJE | Experimental: PF-03446962
Intervention: Drug: PF-03446962 | ||||||
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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 17 | ||||||
Original Estimated Enrollment ICMJE | 26 | ||||||
Actual Study Completion Date ICMJE | February 13, 2015 | ||||||
Actual Primary Completion Date | April 27, 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Previous Therapy Cytotoxic Chemotherapy:
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 ?mol/L; Males: GFR=1.23 x (140-age)x weight in kg serum creatinine in ?mol/L
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01486368 | ||||||
Other Study ID Numbers ICMJE | I207 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
| ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Canadian Cancer Trials Group ( NCIC Clinical Trials Group ) | ||||||
Study Sponsor ICMJE | NCIC Clinical Trials Group | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Canadian Cancer Trials Group | ||||||
Verification Date | April 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |