CancerPhase 1NCT00927823
A Trial To Assess Safety And Tolerability Of PF-04691502 In Cancer Patients
A Phase 1 study testing PF-04691502 in people with Cancer, run by Pfizer at 7 sites in United States.
Trial summary
A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of PF-04691502 in adult cancer patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PF-04691502
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2009to Apr 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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:
- Absolute neutrophil count (ANC) ≥1500 cells/mm3
- Platelets ≥75,000 cells/mm3
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pfizer Investigational Site
Amherst, New York, 14221
Pfizer Investigational Site
Buffalo, New York, 14263
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Los Angeles, California, 90095-6984
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Los Angeles, California, 90404
Pfizer Investigational Site
Santa Monica, California, 90404
About this study
Official title: 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
A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of PF-04691502 in adult cancer patients with solid tumors.
- Conditions
- Cancer
- Being tested
- PF-04691502
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04691502Drug
Once daily continuous dosing. Dose escalation to Maximally tolerated dose (MTD) until progression or discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| PF-04691502 Treatment | Experimental | Not described Receives: Drug: PF-04691502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: Baseline up to 28 days after the last dose
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 and defined as any of the following events occurring after first dose of study medication and considered at least possibly-related to study medication. Hematological: grade 4 neutropenia (absolute neutrophil count [ANC] <500 cells per cubic millimeter [cells/mm^3]) for 1 week or greater, febrile neutropenia (fever >=38.5 degree celsius with ANC <1000/mm^3), grade 3 (50,000 cells/mm^3) and grade 4 (<25,000 cells/mm^3) thrombocytopenia; Non-Hematologic: grade 3 or 4 nausea, vomiting, or diarrhea and any clinically significant grade 3 or greater non-hematologic toxicity, despite the use of adequate/maximal medical intervention and/or prophylaxis, and any persistent, intolerable PF-04691502 related toxicity which delayed retreatment for >14 days.
Measured: Baseline up to Cycle 1 Day 21
Recommended Phase-2 Dose (RP2D)
RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.
Measured: Baseline up to Cycle 1 Day 21
Secondary outcomes (15)
Maximum Observed Plasma Concentration (Cmax)
The pharmacokinetics (PK) of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).
Measured: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 21 (C1D21)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The PK of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).
Measured: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on C1D21
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.
Measured: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeat oral dose administration for 21 days in Cycle 1 (multiple dose PK).
Measured: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours (hrs) post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.
Measured: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where tau is the dosing interval of 24 hours. It was evaluated following repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK) only.
Measured: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21
Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.
Measured: Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT
Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF)
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.
Measured: Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)
Serum glucose level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.
Measured: Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)
Serum insulin level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.
Measured: Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)
Serum C-peptide level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.
Measured: Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21
Fresh tumor biopsy samples analysis included assessment of status of proteins indicative of phosphoinositide 3-kinase/mammalian target of rapamycin (PI3K/mTOR) related pathways signaling status and cell cycle status. The biomarkers included phosphorylated activated kinase (AKT) S473, AKT T308, signal transducer and activator of transcription 3 (STAT3) and forkhead transcription factor Foxo1 (FKHR) T24/forkhead in rhabdomysacoma-like 1 (FKHRL1) T32. The method of analysis was reverse phase microarray (RPMA). The signal (normalized fluorescence unit [NFU]) for each pathway biomarker was normalized against the signal (NFU) for cytokeratin. The final concentration for each pathway biomarker was reported as a cytokeratin normalized fluorescence unit (NFC) value.
Measured: Baseline; 4 hours post-dose on C1D21
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21
Hair follicle biopsy samples analysis included assessment of status of proteins indicative of PI3K/mTOR related pathways signaling status and cell cycle status. The analytes measured were phosphorylated AKT S473, AKT T308, KI67, STAT3 (Y705) and proline-rich Akt substrate of 40 kilodaltons at Thr246 (PRAS40 T246). The method of analysis was reverse phase microarray (RPMA). The signal for each biomarker expressed as normalized fluorescence intensity (NFI) was normalized by their respective total protein concentration. This normalization was performed by dividing the biomarker NFI by total protein concentration (mg/mL) of the sample printed to give total protein normalized fluorescence unit (NFU). All clinical sample test results are reported in NFU.
Measured: Baseline; pre-dose, 2, 4, 24 hours post-dose on C1D21
Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue
Biopsied tumor tissue was analyzed for alterations in the phosphoinositide-3-kinase/rat sarcoma (PI3K/RAS) signaling pathway by molecular approaches. The biomarkers studied were phosphoinositide-3-kinase, catalytic, alpha (PIK3CA) gene mutation, PIK3CA gene amplification, and phosphatase and tensin homolog (PTEN) protein deficiency status by immunohistochemistry.
Measured: Baseline; 4 hours post-dose on C1D21
Number of Participants With Objective Response
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Measured: Baseline, prior to Day 1 of Cycle every odd-numbered cycle or when progressive disease was suspected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927823
- Sponsor's protocol ID
- B1271001
- Status last verified
- Jul 2014
- First submitted
- 23 Jun 2009
- Last updated
- 12 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00927823
- Acronym / sponsor ID
- B1271001
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Posted 12 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of PF-04691502 in adult cancer patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-04691502 Treatment | Experimental | Drug: PF-04691502 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Adequate Renal Function, including:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-04691502Once daily continuous dosing. Dose escalation to Maximally tolerated dose (MTD) until progression or discontinuation. | Drug | PF-04691502 Treatment |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to 28 days after the last dose
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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Baseline up to Cycle 1 Day 21
DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 and defined as any of the following events occurring after first dose of study medication and considered at least possibly-related to study medication. Hematological: grade 4 neutropenia (absolute neutrophil count [ANC] <500 cells per cubic millimeter [cells/mm^3]) for 1 week or greater, febrile neutropenia (fever >=38.5 degree celsius with ANC <1000/mm^3), grade 3 (50,000 cells/mm^3) and grade 4 (<25,000 cells/mm^3) thrombocytopenia; Non-Hematologic: grade 3 or 4 nausea, vomiting, or diarrhea and any clinically significant grade 3 or greater non-hematologic toxicity, despite the use of adequate/maximal medical intervention and/or prophylaxis, and any persistent, intolerable PF-04691502 related toxicity which delayed retreatment for >14 days.
Recommended Phase-2 Dose (RP2D)
Time frame: Baseline up to Cycle 1 Day 21
RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.
15 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 21 (C1D21)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on C1D21
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period
Plasma Decay Half-Life (t1/2)
Time frame: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours (hrs) post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21
Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)
Time frame: Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT
Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF)
Time frame: Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT
Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)
Time frame: Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT
Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)
Time frame: Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT
Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)
Time frame: Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT
Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21
Time frame: Baseline; 4 hours post-dose on C1D21
Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21
Time frame: Baseline; pre-dose, 2, 4, 24 hours post-dose on C1D21
Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue
Time frame: Baseline; 4 hours post-dose on C1D21
Number of Participants With Objective Response
Time frame: Baseline, prior to Day 1 of Cycle every odd-numbered cycle or when progressive disease was suspected
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-04691502 in people with Cancer, run by Pfizer at 7 sites in United States.
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 14 inclusion and 13 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 12 Aug 2014. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: Baseline up to 28 days after the last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2014.