NCT02044861

Brief Summary

ACT-PFK-158 is a novel anti-cancer agent that inhibits glucose uptake in cancer cells. The primary objective of the study will be to determine the maximum tolerated dose (MTD) and to describe any dose limiting toxicity. The secondary objectives of the study will be to determine the safety profile of the drug, to determine the pharmacokinetic profile, to identify any anti-tumor activity, and to determine the pharmacodynamic profile of ACT-PFK-158.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 cancer

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

1.5 years

First QC Date

January 22, 2014

Last Update Submit

June 22, 2015

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    End of cycle 1 (an average of 1 month)

Study Arms (1)

ACT-PFK-158

EXPERIMENTAL

dose escalation

Drug: PFK-158

Interventions

PFK-158DRUG

IV dose escalation

ACT-PFK-158

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or cytological evidence of solid malignancy.
  • Patients must have:
  • a. Have advanced solid tumors that are refractory to established therapies known to provide clinical benefit for the malignancy in question, OR
  • b. Be intolerant of established therapies known to provide clinical benefit for the malignancy in question
  • Patients enrolled in the dose-expansion part of the trial must have at least one lesion that may qualify as a target lesion based on the RECIST 1.1 criteria.
  • Patient is ambulatory with an ECOG performance status of 0, 1 or 2 and an estimated life expectancy of \> 3 months.
  • Patient is 18 years and older.
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
  • Patients must have adequate bone marrow reserve as evidenced by:
  • a. WBC \> 3,000/µL
  • b. Absolute neutrophil count (ANC) ≥ 1,500/µL
  • c. Platelet count ≥ 100,000/µL
  • d. Hemoglobin ≥ 9 gm/dL.
  • Patients must have adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockroft-Gault equation.
  • Patients must have adequate hepatic function as evidenced by AST and ALT values ≤ 3 X ULN (≤ 5 X ULN if the liver is known to be involved by metastatic disease) and serum total bilirubin values of ≤ 1.5 X ULN for the reference laboratory.
  • +5 more criteria

You may not qualify if:

  • Patients with an active infection or with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing.
  • Patients with primary CNS tumors as well as patients with CNS metastases are excluded.
  • Patients with known hypersensitivity to any of the components of PFK-158.
  • Patients who are receiving investigational therapies or who have been treated with investigational therapies or investigational devices within 5 half-lives of the investigational therapy or 4 weeks of first scheduled day of dosing with PFK-158 if the half-live of the investigational agent is not known.
  • Uncontrolled hypertension as defined by SBP \> 160 mm/Hg or DBP \> 100 mm/Hg despite medical therapy.
  • Subjects with diabetes.
  • Patients who require pharmacologic doses of corticosteroids; replacement, topical, ophthalmologic and inhalational steroids are permitted.
  • Patients who require coumadin administration.
  • Patients with mean QTcF values of \> 470 msec (in females) or \> 450 msec (in males) following 3 ECGs conducted 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes; or patients who are on medications known to cause prolonged QT intervals on ECG.
  • Patients with clinically significant cardiovascular co-morbidities including: congestive heart failure (New York Heart Association class III-IV heart disease), unstable angina pectoris, cardiac arrhythmias requiring medication or a pacemaker; myocardial infarction within the past six months; stroke within the past 6 months; or hypertension requiring more than 2 medications for blood pressure control.
  • Patients with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the patient to cooperate and participate in the trial; other examples of such conditions would include COPD or diabetes mellitus that has required 2 or more hospitalizations in the last year; severe peripheral vascular disease; poorly controlled auto-immune conditions; recent serious trauma.
  • Grade 2 or higher peripheral neuropathy.
  • Patients currently known to be positive for, HIV, hepatitis B or C.
  • Patients who are pregnant or lactating.
  • Concurrent or recent (within 1 month) use of thrombolytic agents, or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters). Of note, therapy with low-molecular weight heparin is acceptable as long as the INR \< 2.0.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77230, United States

RECRUITING

UT Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (1)

  • Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.

    PMID: 39462179DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

PFK158

Central Study Contacts

Gilles Tapolsky, PhD

CONTACT

502 589 6404

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

US(4)