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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02044861
Recruitment Status : Unknown
Verified June 2015 by Advanced Cancer Therapeutics.
Recruitment status was:  Recruiting
First Posted : January 24, 2014
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):
Advanced Cancer Therapeutics

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE January 24, 2014
Last Update Posted Date June 23, 2015
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2014)
Maximum Tolerated Dose [ Time Frame: End of cycle 1 (an average of 1 month) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02044861 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase 1 Safety Study of ACT-PFK-158, 2HCl in Patients With Advanced Solid Malignancies
Official Title  ICMJE Phase 1 Open-Label, Dose Escalation, Multi-Center Study of ACT-PFK-158, 2HCl in Patients With Advanced Solid Malignancies
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE Drug: PFK-158
IV dose escalation
Study Arms  ICMJE Experimental: ACT-PFK-158
dose escalation
Intervention: Drug: PFK-158
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 22, 2015)
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histological or cytological evidence of solid malignancy.
  2. 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
  3. 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.
  4. Patient is ambulatory with an ECOG performance status of 0, 1 or 2 and an estimated life expectancy of > 3 months.
  5. Patient is 18 years and older.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Patients must have INR and PTT values ≤ 1.5X ULN for the reference laboratory.
  11. 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.
  12. 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.
  13. Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
  14. 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.

Exclusion Criteria:

  1. Patients with an active infection or with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing.
  2. Patients with primary CNS tumors as well as patients with CNS metastases are excluded.
  3. Patients with known hypersensitivity to any of the components of PFK-158.
  4. 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.
  5. Uncontrolled hypertension as defined by SBP > 160 mm/Hg or DBP > 100 mm/Hg despite medical therapy.
  6. Subjects with diabetes.
  7. Patients who require pharmacologic doses of corticosteroids; replacement, topical, ophthalmologic and inhalational steroids are permitted.
  8. Patients who require coumadin administration.
  9. 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.
  10. 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.
  11. 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.
  12. Grade 2 or higher peripheral neuropathy.
  13. Patients currently known to be positive for, HIV, hepatitis B or C.
  14. Patients who are pregnant or lactating.
  15. 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.
  16. Significant traumatic injury within the past 4 weeks.
  17. Patients who are in-patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02044861
Other Study ID Numbers  ICMJE ACT-PFK-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Advanced Cancer Therapeutics
Study Sponsor  ICMJE Advanced Cancer Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Advanced Cancer Therapeutics
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP