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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall safety profile of PF-04691502 , including Dose Limiting Toxicities (DLTs) and Recommended Phase 2 Dose (RP2D) determination

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1271001

NCT ID:

NCT00927823

Start Date:

December 2009

Completion Date:

April 2012

Related Keywords:

  • Cancer

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteBronx, New York  10461