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CancerPhase 1NCT02044861

Phase 1 Safety Study of ACT-PFK-158, 2HCl in Patients With Advanced Solid Malignancies

A Phase 1 study testing PFK-158 in people with Cancer, run by Advanced Cancer Therapeutics at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
PFK-158
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
4 sitesUnited States
Study dates
Mar 2014to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

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

  • 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.
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  • 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.
  • Patients must have INR and PTT values ≤ 1.5X ULN for the reference laboratory.
  • Patients must be recovered from the effects of any prior chemotherapy, radiotherapy or surgery (i.e., toxicity no worse than Grade 1); for patients who have been on monoclonal antibody therapy, at least one half-life or 4 weeks (whichever is shorter) should have elapsed prior to the first scheduled day of dosing with PFK-158.
  • Patients on prior investigational agents must wait at least 5 half-lives before enrollment into the trial, or 4 weeks if the half-life of the investigational agent is not known.
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
  • Women of childbearing potential and men with female sexual partners of childbearing potential must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device) during the study and for 90 days following the last dose of study medication or to abstain from sexual intercourse for this time; a woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post-menopausal, defined as no menstrual periods for 12 consecutive months.

Who cannot join

  • 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.
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  • 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.
  • Significant traumatic injury within the past 4 weeks.
  • Patients who are in-patients.

Trial locations and contacts

4 sites in 1 country.

Gilles Tapolsky, PhD contact

502 589 6404

United States4 sites, 4 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77230

    Siqing Fu, MD PhD, 713-742-4318, siqingfu@mdanderson.org

    Jing Gong, RN, 713-563-8392, jinggong@mdanderson.org

    Recruiting

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

    Rebecca Redman, MD, 502-562-4673, rebecca.redman@louisville.edu

    Rebecca Redman, MD

    Recruiting

  • UT Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Devalingam Mahalingam, MD PhD, 210-450-5970, Mahalingam@uthscsa.edu

    Patricia O'Rourke, RN, 210-450-5976, ORourkeP@uthscsa.edu

    Recruiting

  • Lombardi Comprehensive Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

    Paula R Pohlmann, MD, PhD, 202-444-4655, Paula.R.Pohlmann@gunet.georgetown.edu

    Paula R Pohlmann, MD PhD

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 Open-Label, Dose Escalation, Multi-Center Study of ACT-PFK-158, 2HCl in Patients With Advanced Solid Malignancies

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.

Conditions
Cancer
Being tested
PFK-158
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PFK-158Drug

    IV dose escalation

Study groups in NCT02044861
Study groupRoleWhat they receive
ACT-PFK-158Experimentaldose escalation
Receives: Drug: PFK-158

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose

    Measured: End of cycle 1 (an average of 1 month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionSep 2015 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02044861
Sponsor's protocol ID
ACT-PFK-01
Status last verified
Jun 2015
First submitted
22 Jan 2014
Last updated
23 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39462179

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PFK-158 in people with Cancer, run by Advanced Cancer Therapeutics at 4 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 20 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gilles Tapolsky, PhD (502 589 6404), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (time frame: End of cycle 1 (an average of 1 month)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02044861, which also lists 1 linked publication.

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 23 Jun 2015.

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