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Phase 1 Study of PTX-100 in Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT03900442
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Prescient Therapeutics, Ltd.

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date September 22, 2021
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2021)
  • Investigate the time- and dose-dependent PD of multiple doses of PTX-100 in patients with advanced malignancies (RAP-1) [ Time Frame: One Cycle (cycle = 14 days) ]
    PD endpoints will be based on analysis of level of RAP-1 geranylgeranylation proteins in PBMNCs and tumor biopsies:
  • Investigate the time- and dose-dependent PD of multiple doses of PTX-100 in patients with advanced malignancies (PD endpoints) [ Time Frame: One Cycle (cycle = 14 days) ]
    PD endpoints will be based on analysis of the level of DJ2 farnesylation proteins in PBMNCs and tumor biopsies:
  • Investigate the time- and dose-dependent PK of multiple doses of PTX-100 in patients with advanced malignancies (cmax) [ Time Frame: One Cycle (cycle = 14 days) ]
    Pharmacokinetics will be evaluated by PK parameters calculated from plasma concentrations of PTX 100. Individual and mean plasma concentrations of PTX-100 versus time as well as individual and mean PK parameters will be determined, for the following: • Maximum observed plasma concentration (Cmax)
  • Investigate the time- and dose-dependent PK of multiple doses of PTX-100 in patients with advanced malignancies (Tmax) [ Time Frame: One Cycle (cycle = 14 days) ]
    Pharmacokinetics will be evaluated by PK parameters calculated from plasma concentrations of PTX 100. Individual and mean plasma concentrations of PTX-100 versus time as well as individual and mean PK parameters will be determined, for the following: • Time to maximum observed plasma concentration (Tmax)
  • Investigate the time- and dose-dependent PK of multiple doses of PTX-100 in patients with advanced malignancies (half life) [ Time Frame: One Cycle (cycle = 14 days) ]
    Pharmacokinetics will be evaluated by PK parameters calculated from plasma concentrations of PTX 100. Individual and mean plasma concentrations of PTX-100 versus time as well as individual and mean PK parameters will be determined, for the following: • Apparent elimination half-life (t1/2)
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2019)
  • Investigate the time- and dose-dependent PD of multiple doses of PTX-100 in patients with advanced malignancies [ Time Frame: One Cycle (cycle = 14 days) ]
    PD endpoints will be based on analysis of level of RAP-1 geranylgeranylation proteins in PBMNCs and tumor biopsies:
  • Investigate the time- and dose-dependent PD of multiple doses of PTX-100 in patients with advanced malignancies [ Time Frame: One Cycle (cycle = 14 days) ]
    PD endpoints will be based on analysis of the level of DJ2 farnesylation proteins in PBMNCs and tumor biopsies:
  • Investigate the time- and dose-dependent PK of multiple doses of PTX-100 in patients with advanced malignancies [ Time Frame: One Cycle (cycle = 14 days) ]
    Pharmacokinetics will be evaluated by PK parameters calculated from plasma concentrations of PTX 100. Individual and mean plasma concentrations of PTX-100 versus time as well as individual and mean PK parameters will be determined, for the following: • Maximum observed plasma concentration (Cmax)
  • Investigate the time- and dose-dependent PK of multiple doses of PTX-100 in patients with advanced malignancies [ Time Frame: One Cycle (cycle = 14 days) ]
    Pharmacokinetics will be evaluated by PK parameters calculated from plasma concentrations of PTX 100. Individual and mean plasma concentrations of PTX-100 versus time as well as individual and mean PK parameters will be determined, for the following: • Time to maximum observed plasma concentration (Tmax)
  • Investigate the time- and dose-dependent PK of multiple doses of PTX-100 in patients with advanced malignancies [ Time Frame: One Cycle (cycle = 14 days) ]
    Pharmacokinetics will be evaluated by PK parameters calculated from plasma concentrations of PTX 100. Individual and mean plasma concentrations of PTX-100 versus time as well as individual and mean PK parameters will be determined, for the following: • Apparent elimination half-life (t1/2)
Change History
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 Study of PTX-100 in Patients With Advanced Malignancies
Official Title  ICMJE Phase 1 Pharmacodynamic and Pharmacokinetic Study of the Geranylgeranyltransferase I Inhibitor PTX-100 (GGTI-2418) in Patients With Advanced Malignancies
Brief Summary

This is an open-label, non-randomized study to evaluate the PD, PK, and safety of 500 to 2000 mg/m2 PTX-100 in patients with advanced malignancies.

PTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles unless toxicity is observed.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Drug: PTX-100
Doses of 500 to 2000 mg/m2 will be administered.
Study Arms  ICMJE Experimental: PTX-100
IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles
Intervention: Drug: PTX-100
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Biopsy proven multiple myeloma (MM), peripheral T-cell lymphoma (CTCL, AITL or PTCL-NOS), colo-rectal cancer (CRC), pancreas cancer (PANC), or diffuse gastric cancer (DGC)
  2. Must have a relapsed or refractory advanced malignancy for which no standard therapy exists.
  3. Must have at least 6 unstained slides of archived formalin-fixed, paraffin-embedded tumor tissue available for genotyping studies; if insufficient or no archived tissue is available, a fresh tumor biopsy within 30 days prior to Cycle 1/Day 1 is mandatory.
  4. Age ≥ 18 years
  5. ECOG performance status ≤ 2
  6. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1000/mm3, platelet count ≥ 50,000 mm3
  7. Adequate hepatic function: total bilirubin ≤ 1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (patients with liver metastases may be enrolled with elevated hepatic function based on Medical Monitor and Investigator review and agreement)
  8. Adequate renal function: measured, calculated or estimated creatinine clearance of ≥ 50 mL/min
  9. Female patients of childbearing potential must have a negative serum pregnancy test at screening and agree to use dual methods of contraception. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose.
  10. Informed consent (current IRB approved version) must be obtained from the patient or legally authorized representative prior to any study-related procedures.

Exclusion Criteria:

  1. Radiation, chemotherapy, immunotherapy, or any other approved anticancer therapy ≤ 2 weeks prior to study treatment
  2. Participation in another interventional investigational drug study within 4 weeks prior to enrollment
  3. Concurrent radiation, chemotherapy, immunotherapy, or any other approved or investigational anticancer therapeutic (Patients are allowed to receive ≤ 10 mg/day corticosteroids for the treatment of non malignant disorders.)
  4. Myocardial infarction within 6 months before screening, New York Heart Association Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  5. Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose (Patients with controlled infection or on prophylactic antibiotics are permitted in the study.)
  6. Known to be HIV seropositive
  7. Known active hepatitis A, B, or C infection or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
  8. Grade > 2 peripheral neuropathy at screening
  9. Previous allogeneic transplant within the past 6 months or evidence of clinically significant graft-versus-host disease (if prior bone marrow transplant)
  10. Any history of malignancy, other than that treated in this study, unless the patient has remained free of the disease for over 3 years (except for properly treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast)
  11. Any active medical or psychiatric illness that, in the judgement of the investigator, may interfere with adherence to the protocol
  12. Any malignancy with CNS involvement
  13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to PTX-100
  14. Female patients who are pregnant or lactating
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: Claudia
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03900442
Other Study ID Numbers  ICMJE PTX-100-PD-012017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prescient Therapeutics, Ltd.
Study Sponsor  ICMJE Prescient Therapeutics, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Terrence Chew, MD Prescient Therapeutics, Ltd.
PRS Account Prescient Therapeutics, Ltd.
Verification Date September 2021

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