A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients
NCT00927823
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Patients with a histologically or cytologically confirmed malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
- Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours of the first dose of PF-04961502, These patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the Principal Investigator or a designated associate
- Adequate Bone Marrow Function, including:
1. Absolute neutrophil count (ANC) ≥1500 cells/mm3
2. Platelets ≥75,000 cells/mm3
3. Hemoglobin ≥9 mg/dL
- Adequate Renal Function, including:
SrCr <1.5 x ULN (upper limit of normal). OR Estimated creatinine clearance ≥60 mL/min, as calculated using method standard for the institution
- Adequate Liver Function, including:
Bilirubin ≤1.5 x ULN AST (SGOT) ≤2.5 x ULN ALT (SGPT) ≤2.5 x ULN
- Adequate glucose control, including no previous diagnosis of diabetes mellitus and HbA1c <7%.
- Adequate Cardiac Function, including:
12-Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention. QTc interval ≤470 msec and no history of Torsades des Pointes or other symptomatic QTc abnormality
- Patients with known active brain metastases. Patients with previously diagnosed brain
metastases are eligible if they have completed their CNS treatment and have recovered
from the acute effects of radiation therapy or surgery prior to the start of study
medication, have discontinued corticosteroid treatment for these metastases for at
least 4 weeks and are neurologically stable
- Chemotherapy, radiotherapy (other than palliative radiotherapy to lesions that will
not be followed for tumor assessment on this study, ie, non target lesions),
biological or investigational agents within 2 weeks of Baseline disease assessments
- Any surgery (not including minor procedures such as lymph node biopsy) within 4 weeks
of Baseline disease assessments; or not fully recovered from any side effects of
previous procedures
- Prior therapy with an agent that is known or proposed to be active by action on PI3K
and/or mTOR
- Prior high-dose chemotherapy requiring hematopoetic stem cell transplantation within
12 months of study treatment start
- Uncontrolled or significant cardiovascular disease:
A myocardial infarction within 12 months Uncontrolled angina within 6 months Congestive
heart failure within 6 months. Diagnosed or suspected congenital long QT syndrome. Any
history of ventricular arrhythmias (such as ventricular tachycardia, ventricular
fibrillation, or Torsades de pointes). Any history of second or third degree heart block
(may be eligible if currently have a pacemaker) Heart rate <50/minute on pre-entry
electrocardiogram Uncontrolled hypertension.
- Current use or anticipated need for food or drugs that are known potent CYP3A4
inhibitors or inducers
- Current use or anticipated need for food or drugs that are known potent CYP1A2
inhibitors or inducers
- Concurrent administration of herbal preparations
- Breast feeding: No studies have been conducted in humans to assess the impact of
PF-04691502 on milk production, its presence in breast milk and its effects on the
breast-fed child. Because drugs are commonly excreted in human milk and because of the
potential for serious adverse reactions in nursing infants, lactating female patients
are excluded from this study.
- Any clinically significant gastrointestinal abnormalities, which may impair intake,
transit or absorption of the study drug, such as the inability to take oral medication
in tablet form and malabsorption syndrome.
- Any mental disorder that would limit the understanding or rendering of informed
consent and/or compromise compliance with the requirements of this protocol
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients | |||
| Official Title ICMJE | A Phase 1, Open-Label, Dose-Escalation Study To Evaluate Safety, Pharmacokinetics, And Pharmacodynamics Of The PI3K/MTOR Inhibitor PF-04691502 In Adult Patients With Advanced Malignant Solid Tumors | |||
| Brief Summary | A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of PF-04691502 in adult cancer patients with solid tumors. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Cancer | |||
| Intervention ICMJE | Drug: PF-04691502
Once daily continuous dosing. Dose escalation to Maximally tolerated dose (MTD) until progression or discontinuation. | |||
| Study Arms ICMJE | Experimental: PF-04691502 Treatment
Intervention: Drug: PF-04691502 | |||
| Publications * | Not Provided | |||
* 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 | 37 | |||
| Original Estimated Enrollment ICMJE | 75 | |||
| Actual Study Completion Date ICMJE | April 2012 | |||
| Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
SrCr <1.5 x ULN (upper limit of normal). OR Estimated creatinine clearance ?60 mL/min, as calculated using method standard for the institution
Bilirubin ?1.5 x ULN AST (SGOT) ?2.5 x ULN ALT (SGPT) ?2.5 x ULN
Exclusion Criteria:
A myocardial infarction within 12 months Uncontrolled angina within 6 months Congestive heart failure within 6 months. Diagnosed or suspected congenital long QT syndrome. Any history of ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes). Any history of second or third degree heart block (may be eligible if currently have a pacemaker) Heart rate <50/minute on pre-entry electrocardiogram Uncontrolled hypertension.
| |||
| 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 | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00927823 | |||
| Other Study ID Numbers ICMJE | B1271001 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||