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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03900442




Registration number
NCT03900442
Ethics application status
Date submitted
13/03/2019
Date registered
3/04/2019
Date last updated
3/06/2022

Titles & IDs
Public title
Phase 1 Study of PTX-100 in Patients With Advanced Malignancies With PTCL Expansion Cohort
Scientific title
Phase 1 Pharmacodynamic and Pharmacokinetic Study of the Geranylgeranyltransferase I Inhibitor PTX-100 (GGTI-2418) in Patients With Advanced Malignancies
Secondary ID [1] 0 0
PTX-100-PD-012017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
PTCL 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PTX-100

Experimental: PTX-100 - IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles


Treatment: Drugs: PTX-100
Doses of 500 to 2000 mg/m2 will be administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigate the time- and dose-dependent PD of multiple doses of PTX-100 in patients with advanced malignancies (RAP-1)
Timepoint [1] 0 0
One Cycle (cycle = 14 days)
Primary outcome [2] 0 0
Investigate the time- and dose-dependent PD of multiple doses of PTX-100 in patients with advanced malignancies (PD endpoints)
Timepoint [2] 0 0
One Cycle (cycle = 14 days)
Primary outcome [3] 0 0
Investigate the time- and dose-dependent PK of multiple doses of PTX-100 in patients with advanced malignancies (cmax)
Timepoint [3] 0 0
One Cycle (cycle = 14 days)
Primary outcome [4] 0 0
Investigate the time- and dose-dependent PK of multiple doses of PTX-100 in patients with advanced malignancies (Tmax)
Timepoint [4] 0 0
One Cycle (cycle = 14 days)
Primary outcome [5] 0 0
Investigate the time- and dose-dependent PK of multiple doses of PTX-100 in patients with advanced malignancies (half life)
Timepoint [5] 0 0
One Cycle (cycle = 14 days)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [2] 0 0
Epworth Healthcare - Melbourne
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prescient Therapeutics, Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.

Dose escalation is complete and the expansion is open and actively recruiting PTCL patients.
Trial website
https://clinicaltrials.gov/study/NCT03900442
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Terrence Chew, MD
Address 0 0
Prescient Therapeutics, Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Leanne West
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03900442