Trial · NCT00666926
Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms
NCT00666926, Phase 1, Completed, Verastem, Inc.; results first posted 2012-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms. Trials, record NCT00666926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00666926
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms
- NCT number
- NCT00666926
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 99 participants, actual
- Lead sponsor
- Verastem, Inc.
- Conditions
- Head and Neck Neoplasm, Prostatic Neoplasm, Pancreatic Neoplasm
- Interventions
- PF00562271, PF00562271, PF00562271, PF00562271
- First posted
- 2008-04-25
- Last updated
- 2013-03-21
- Results first posted
- 2012-06-14
- Limitations and caveats
PET and RECIST Response Analysis Sets as defined in Protocol Amendment 3 dated 20Mar2007 are reported in Basic Results per the revised definitions in Statistical Analysis Plan version 2 dated 11Apr2008.
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | Baseline up to Cycle 1 Day 21 (C1.D21) | At least possibly attributable to study treatment (Tx): Grade (Gr) 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells/mm\^3) for \>7 days or Gr 3 febrile neutropenia (ANC \<1000/mm\^3, fever ≥38 degrees Celsius; Gr 4 thrombocytopenia (platelets \<25,000 cells/mm\^3); Gr ≥3 non-hematologic toxicity despite adequate medical intervention; Gr ≥3 confirmed prolonged QTc interval (\>500 milliseconds \[msec\]); confirmed cardiac troponin I ≥99 percentile of reference range; Tx related toxicities with failure to receive ≥18 days Tx in 21-day cycle or inability to resume current dose level ≤14 days. |
| Primary | Percentage of Participants With Tumor Metabolic Response (Reduction of ≥15%) in Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET) | Baseline, C1.D14 | Metabolic response demonstrated in any tumor reduction of ≥15% in tumor FDG standardized uptake value (SUV) in Cycle 1; based on the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Participant must have had a baseline PET with at least 1 tumor lesion demonstrating an FDG SUV of ≥5. |
| Secondary | Maximum Serum Concentration (Cmax): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 morning (am) dose | |
| Secondary | Maximum Serum Concentration (Cmax): PF-00562271 C1.D14 | Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose | |
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | |
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C1.D14 | Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose | |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | Area under the serum concentration time-curve from zero to the last measured concentration; nanograms multiplied by hours per milliliters (ng\*hr/mL). |
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). |
| Secondary | Serum Decay Half-life (t 1/2): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | Serum decay half-life is the time measured for the serum concentration to decrease by one half. |
| Secondary | Apparent Oral Clearance (CL/F): PF-00562271 C0. D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | Baseline up to Cycle 1 Day 21 (C1.D21) | Safety analysis set: All enrolled participants who started treatment. | participants | NUMBER |
| PRIMARY | Percentage of Participants With Tumor Metabolic Response (Reduction of ≥15%) in Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET) | Baseline, C1.D14 | Participants in the 125 mg BID expansion cohort with at least 1 dose of study treatment, at least 1 lesion with an SUV ≥5 at baseline, and an on-study PET assessment C1.D14 (Day 13 up to Day 17). | percentage of participants | NUMBER |
| SECONDARY | Maximum Serum Concentration (Cmax): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 morning (am) dose | Pharmacokinetic (PK) parameter analysis set: all participants with at least 1 dose of study treatment and at least 1 of the PK parameters of interest estimated in at least 1 treatment period. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Serum Concentration (Cmax): PF-00562271 C1.D14 | Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose | PK parameter analysis set | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1. | hours | MEDIAN |
| SECONDARY | Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C1.D14 | Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose | PK parameter analysis set | hours | MEDIAN |
| SECONDARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Serum Decay Half-life (t 1/2): PF-00562271 C0.D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1. | hours | MEAN |
| SECONDARY | Apparent Oral Clearance (CL/F): PF-00562271 C0. D1, C1.D1 | Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose | PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1. | milliliters per minute (mL/min) | GEOMETRIC_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group279
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 5 mg BID | 0 | participants | ||
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 10 mg BID | 0 | participants | ||
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 15 mg BID | 0 | participants | ||
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 25 mg BID | 0 | participants | ||
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 35 mg BID | 0 | participants | ||
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 45 mg BID | 0 | participants | ||
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 60 mg BID | 0 | participants | ||
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 75 mg BID | 0 | participants | ||
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 80 mg BID | 0 | participants | ||
| Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) | PF-00562271 100 mg BID | 0 | participants |
1 to 10 of 279Source ClinicalTrials.gov
See all 279 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-00562271 5 mg BID | 2 | |
| Overall Study | STARTED | PF-00562271 10 mg BID | 4 | |
| Overall Study | STARTED | PF-00562271 15 mg BID | 3 | |
| Overall Study | STARTED | PF-00562271 25 mg BID | 4 | |
| Overall Study | STARTED | PF-00562271 35 mg BID | 3 | |
| Overall Study | STARTED | PF-00562271 45 mg BID | 4 | |
| Overall Study | STARTED | PF-00562271 60 mg BID | 4 | |
| Overall Study | STARTED | PF-00562271 75 mg BID | 1 | |
| Overall Study | STARTED | PF-00562271 80 mg BID | 3 | |
| Overall Study | STARTED | PF-00562271 100 mg BID | 10 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events3,328
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 5 mg BID | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 10 mg BID | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 15 mg BID | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 25 mg BID | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 35 mg BID | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 45 mg BID | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 60 mg BID | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 75 mg BID | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 80 mg BID | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-00562271 100 mg BID | 0 | 10 |
1 to 10 of 3,328Source ClinicalTrials.gov
See all 3,328 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-00562271 5 mg BID | ||
| Total, all-cause mortality | PF-00562271 10 mg BID | ||
| Total, all-cause mortality | PF-00562271 15 mg BID | ||
| Total, all-cause mortality | PF-00562271 25 mg BID | ||
| Total, all-cause mortality | PF-00562271 35 mg BID | ||
| Total, all-cause mortality | PF-00562271 45 mg BID | ||
| Total, all-cause mortality | PF-00562271 60 mg BID | ||
| Total, all-cause mortality | PF-00562271 75 mg BID | ||
| Total, all-cause mortality | PF-00562271 80 mg BID | ||
| Total, all-cause mortality | PF-00562271 100 mg BID |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00666926
GET https://conductscience.org/api/trials/v1/NCT00666926/registered?page=2