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PF00562271

Phase 1

Head and Neck Neoplasm | Small molecule | Oncology |Verastem, Inc.|Last Updated: Mar 21, 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

PF00562271 · 1 trial · 3 indications

Phase 1 1
NCT00666926Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic NeoplasmsHead and Neck Neoplasm
COMPLETED99 Analytics
PHASE1COMPLETED
Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms
Head and Neck NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

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 Endpoints

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
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
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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -

Interventions

NameTypeDescription
PF00562271DRUG125 mg twice daily \[BID\] with food, tablet
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Pancreatic, head and neck, and prostatic neoplasms, and patients with non-hematologic malignancies who have tumor appropriate for serial biopsy. * Adequate organ function, including bilirubin less than 1.5 x ULN, and \[Eastern Cooperative Oncology Group\] ECOG performance stat...

Countries:United StatesAustraliaCanada
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Frequently asked questions about PF00562271

What is PF00562271 used for?

PF00562271 is an investigational small molecule being studied for the treatment of head and neck neoplasms. It was evaluated in a Phase 1 clinical trial that also included patients with pancreatic and prostatic neoplasms. The drug is not approved and remains in clinical development.

What does PF00562271 target?

PF00562271 is a small molecule developed for oncology. Its specific molecular target has not been disclosed in the available information. The drug was studied in a Phase 1 trial for head and neck, pancreatic, and prostatic neoplasms.

Who makes PF00562271?

PF00562271 is being developed by Verastem, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VSTM. The company conducted a Phase 1 clinical trial of the drug in patients with head and neck, pancreatic, and prostatic neoplasms.

What phase is PF00562271 in?

PF00562271 is in Phase 1 clinical development. It has completed one Phase 1 trial, which enrolled 99 patients. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF00562271 in?

PF00562271 has one completed clinical trial, NCT00666926, titled 'Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms.' This Phase 1 study enrolled 99 patients across the United States, Australia, and Canada.

Is PF00562271 the same as PF-00562271?

Yes, PF00562271 and PF-00562271 refer to the same investigational drug. The clinical trial NCT00666926 uses the name PF-00562271, while the drug is also referred to as PF00562271 in development records.