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Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

Primary Purpose

Adenocarcinoma, Neoplasms

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Torisel

About this trial

This is an interventional treatment trial for Adenocarcinoma focused on measuring Pediatric Tumors

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion Criteria: Part 1 only: - Subjects with a histological diagnosis of advanced cancer (solid tumors or central nervous system [CNS] tumors) with disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available (histological confirmation waived for brain stem gliomas and optic pathway tumors) Part 2 only: Subjects with histologically confirmed diagnosis of refractory or relapsed: Neuroblastoma, High-grade gliomas: glioblastoma multiforme, anaplastic astrocytomas, and other high-grade gliomas (histological confirmation waived for brain stem gliomas), Rhabdomyosarcoma. Measurable disease (for subjects with neuroblastoma, evaluable disease as determined by a positive metaiodobenzylguanidine (MIBG) scan will also be permitted). Exclusion Criteria: Exclusion Criteria: Subjects receiving enzyme-inducing anticonvulsants. Pulmonary hypertension or pneumonitis Active infection or serious intercurrent illness Other exclusions apply

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1.0

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 1

Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 1

TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period. National Cancer Institute (NCI)-graded Common Toxicity Criteria (CTC) provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).

Number of Participants Who Died: Part 1

Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).

Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 1

SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability / incapacity or are a congenital anomaly or birth defect in the offspring of a study subject. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.

Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 1

Temporary interruption of study treatment; may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.

Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 1

Dose reduction for individual participant allowed if a dose limiting toxicity (DLT) occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.

Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 1

Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees Celsius (C), respiratory rate >20 beats per minute (bpm), and systolic and diastolic blood pressure (BP) >200/110 millimeters of mercury (mmHg). Participants may be reported in more than 1 category.

Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 1

Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.

Percentage of Participants With Objective Response (OR) at Week 12: Part 2

Measured as Complete response (CR), Very good partial response (VGPR), or Partial response (PR) on at least 2 occasions greater than or equal to (>=) 4 weeks apart within first 12 weeks. CR=disappearance of all primary and metastatic lesions; Homovanillic acid, Vanillymandelic acid (HVA/VMA) normal; bone marrow immunocytology negative. VGPR=disappearance of all metastatic lesions (residual areas of uptake on bone permitted); 90 to 99 percent (%) decrease in primary disease measurement; HVA/VMA normal or both decreased >90%. PR=at least 50% decrease in primary and metastatic disease. Number of bone sites decreased by at least 50%.

Secondary Outcome Measures

Number of Participants Who Reached Maximum Tolerated Dose Due to Dose Limiting Toxicity: Part 1

Maximum tolerated dose (MTD) defined as the dose level at which >=2 of 3 participants or >=2 of 6 participants if the dose level had been expanded, experienced a dose limiting toxicity (DLT) by day 21 after the first dose of study treatment. DLT defined as failure to recover to NCI-CTCAE version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of > 3 weeks) unless the investigator and the medical monitor agree that the subject should remain in the study.

Maximum Observed Plasma Concentration (Cmax): Part 1

Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 1

Plasma Decay Half-Life (t1/2): Part 1

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 1

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).

Area Under the Concentration-Time Curve (AUC): Part 1

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Clearance (CL): Part 1

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Volume of Distribution at Steady State (Vss): Part 1

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Percentage of Participants With Best Overall Response: Part 1

Best overall response is the best response recorded from baseline until disease progression or recurrence. Measured as CR, PR, SD, PD, or Unknown. CR=disappearance of all primary and metastatic lesions. PR=at least a 50% decrease in primary disease measurement. SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=any new lesion; at least a 25% increase in any disease measurement (reference smallest disease measurement recorded since start of treatment); or appearance of 1 or more new lesions. Tumor response considered Unknown if assessment prior to Day 37.

Percentage of Participants Exhibiting Freedom From Progression at Week 12: Part 2

Freedom from progression measured as Stable Disease (SD) or better and no Progressive Disease (PD); (CR+VGPR+Mixed Response [MR]+PR+SD). CR=disappearance of all primary and metastatic lesions. VGPR=disappearance of all metastatic lesions. MR=no new lesions; at least 50% decrease in any 1 disease measurement with <50% decrease in any other disease measurement or an increase of <25% in any lesion). SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=at least a 25% increase in any disease measurement; or the appearance of 1 or more new lesions.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2

Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 2

Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 2

Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).

Number of Participants Who Died: Part 2

Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 2

An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.

Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 2

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Temporary interruption of study treatment may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.

Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 2

Dose reduction for individual participant allowed if a DLT occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.

Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 2

Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees C, respiratory rate >20 bpm, and systolic and diastolic BP >200/110 mmHg. Participants may be reported in more than 1 category.

Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 2

Maximum Observed Plasma Concentration (Cmax): Part 2

Average Plasma Concentration (Cavg): Part 2

Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 2

Plasma Decay Half-Life (t1/2): Part 2

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 2

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Area Under the Concentration-time Curve at Steady State (AUCss): Part 2

AUCss is a measure of the serum concentration of the drug at steady state. It is used to characterize drug absorption.

Clearance (CL): Part 2

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Concentration in Plasma (Cp) and Concentration in Plasma at Time Zero (Cp Time 0): Part 1 and Part 2

Pharmacokinetic parameters determined in whole blood; derived from the concentration-versus-time profiles using noncompartmental analysis method. Measured as nanograms per milliliter (ng/mL).

Number of Participants for Change From Baseline in the Phosphorylation of Mammalian Target of Rapamycin (mTOR) Pathway Proteins: Part 1 and Part 2

Optional bone marrow sampling for pharmacodynamic analysis of effects of study treatment. Data may not be collected for a majority of patients and was not to be summarized if collection was sparse.

Full Information

NCT ID

NCT00106353

First Posted

March 22, 2005

Last Updated

January 4, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00106353

Brief Title

Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

Official Title

A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma, Neoplasms

Keywords

Pediatric Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1.0

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Torisel

Other Intervention Name(s)

temsirolimus

Intervention Description

60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1

Description

Time Frame

Baseline up to End of Treatment (EOT) (within 30 days of last dose)

Title

Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 1

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 1

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants Who Died: Part 1

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 1

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 1

Description

Temporary interruption of study treatment; may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 1

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 1

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 1

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Percentage of Participants With Objective Response (OR) at Week 12: Part 2

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Number of Participants Who Reached Maximum Tolerated Dose Due to Dose Limiting Toxicity: Part 1

Description

Time Frame

Baseline up to Month 6

Title

Maximum Observed Plasma Concentration (Cmax): Part 1

Time Frame

0 (pre-dose), 1, 2, 6, 24, and 168 hours (hrs) post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 1

Time Frame

0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Plasma Decay Half-Life (t1/2): Part 1

Description

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time Frame

0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 1

Description

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).

Time Frame

0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Area Under the Concentration-Time Curve (AUC): Part 1

Description

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

Time Frame

0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Clearance (CL): Part 1

Description

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Time Frame

0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Volume of Distribution at Steady State (Vss): Part 1

Description

Time Frame

0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Percentage of Participants With Best Overall Response: Part 1

Description

Time Frame

Baseline until disease progression or recurrence (actual greatest response day is up to Day 49)

Title

Percentage of Participants Exhibiting Freedom From Progression at Week 12: Part 2

Description

Time Frame

Week 12

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 2

Description

Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 2

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants Who Died: Part 2

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 2

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 2

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 2

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 2

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 2

Description

Time Frame

Baseline up to EOT (within 30 days of last dose)

Title

Maximum Observed Plasma Concentration (Cmax): Part 2

Time Frame

0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Average Plasma Concentration (Cavg): Part 2

Time Frame

0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 2

Time Frame

0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Plasma Decay Half-Life (t1/2): Part 2

Description

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time Frame

0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 2

Description

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Time Frame

0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Area Under the Concentration-time Curve at Steady State (AUCss): Part 2

Description

AUCss is a measure of the serum concentration of the drug at steady state. It is used to characterize drug absorption.

Time Frame

0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Clearance (CL): Part 2

Description

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Time Frame

0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Concentration in Plasma (Cp) and Concentration in Plasma at Time Zero (Cp Time 0): Part 1 and Part 2

Description

Pharmacokinetic parameters determined in whole blood; derived from the concentration-versus-time profiles using noncompartmental analysis method. Measured as nanograms per milliliter (ng/mL).

Time Frame

Part 1: 0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2; Part2: 0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)

Title

Number of Participants for Change From Baseline in the Phosphorylation of Mammalian Target of Rapamycin (mTOR) Pathway Proteins: Part 1 and Part 2

Description

Optional bone marrow sampling for pharmacodynamic analysis of effects of study treatment. Data may not be collected for a majority of patients and was not to be summarized if collection was sparse.

Time Frame

Part 1:Baseline,1,2,6,24,168 hrs post-dose of Cycle 1;additional 0 (Pre-dose),24,72,96 hrs, Day 16 to 21 of cycle 2, EOT(within 30 days of last dose); Part 2:Baseline,Day16 to 21 in Cycle 2, at time of disease progression, EOT(within 30 days of last dose)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Pfizer Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

Pfizer Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104-4318

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Pfizer Investigational Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Pfizer Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105-2794

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-2399

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pfizer Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Pfizer Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3B 6A8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3V4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Halifax,

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Name

Pfizer Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Paris Cedex 05

ZIP/Postal Code

75248

Country

France

Facility Name

Pfizer Investigational Site

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Pfizer Investigational Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Pfizer Investigational Site

City

Mexico City

ZIP/Postal Code

04530

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Lublin

ZIP/Postal Code

20- 093

Country

Poland

Facility Name

Pfizer Investigational Site

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

117513

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Saint Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

22033322

Citation

Geoerger B, Kieran MW, Grupp S, Perek D, Clancy J, Krygowski M, Ananthakrishnan R, Boni JP, Berkenblit A, Spunt SL. Phase II trial of temsirolimus in children with high-grade glioma, neuroblastoma and rhabdomyosarcoma. Eur J Cancer. 2012 Jan;48(2):253-62. doi: 10.1016/j.ejca.2011.09.021. Epub 2011 Oct 25.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-139&StudyName=Study%20Evaluating%20Biomarkers%20In%20Relapsed/Refractory%20Pediatric%20Solid%20Tumors

Description

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Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

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Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

Adenocarcinoma, Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial