Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05141149




Registration number
NCT05141149
Ethics application status
Date submitted
27/08/2021
Date registered
2/12/2021
Date last updated
4/06/2025

Titles & IDs
Public title
First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients With Pancreatic Cancer
Scientific title
A First in Human, Phase 1/2a, Multicentre, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of PBP1510 in Patients With Advanced/Metastatic Pancreatic Cancer
Secondary ID [1] 0 0
2024-514379-16-00
Secondary ID [2] 0 0
PAUF-I
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PBP1510 (400mg/16mL)
Treatment: Drugs - Gemcitabine (1000 mg/m^2)

Experimental: Cohort 1M - 1 mg/kg of PBP1510 as monotherapy will be administered

Experimental: Cohort 1C - 1 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Experimental: Cohort 2M - 3 mg/kg of PBP1510 as monotherapy will be administered

Experimental: Cohort 2C - 3 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Experimental: Cohort 3M - 6 mg/kg of PBP1510 as monotherapy will be administered

Experimental: Cohort 3C - 6 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Experimental: Cohort 4M - 10 mg/kg of PBP1510 as monotherapy will be administered

Experimental: Cohort 4C - 10 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered

Experimental: Cohort 5M - 15 mg/kg of PBP1510 as monotherapy will be administered

Experimental: Cohort 5C - 15 mg/kg of PBP1510 and 1000 mg/m\^2 of gemcitabine as combination therapy will be administered


Treatment: Drugs: PBP1510 (400mg/16mL)
Humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets and neutralizes PAUF, administered as a 90-minute intravenous infusion

Treatment: Drugs: Gemcitabine (1000 mg/m^2)
Humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets and neutralizes PAUF, administered as a 90-minute intravenous infusion in combination with 1000 mg/m2 gemcitabine administered as a 30-minute intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PART 1 (PHASE 1): To evaluate safety and tolerability of PBP1510
Timepoint [1] 0 0
Baseline to Safety Follow Up visit (90 days after last dose of PBP1510)
Primary outcome [2] 0 0
PART 1 (PHASE 1): Dose limiting toxicity (DLT) evaluation
Timepoint [2] 0 0
During first treatment cycle (each cycle is 28 days)
Primary outcome [3] 0 0
PART 2 (PHASE 2a): To establish safety of PBP1510 in combination with gemcitabine
Timepoint [3] 0 0
Baseline to Safety Follow Up visit (90 days after last dose of PBP1510)
Primary outcome [4] 0 0
PART 2 (PHASE 2a): To assess the efficacy of PBP1510 in combination with gemcitabine
Timepoint [4] 0 0
Baseline to End of Treatment visit (28 days after last dose of PBP1510)
Primary outcome [5] 0 0
PART 1 (PHASE 1): Determine the recommended Phase 2a dose (R2PD) of PBP1510
Timepoint [5] 0 0
After last patient enrolled in last dosing cohort completes 4 cycles of treatment. Each cycle is 28 days.
Secondary outcome [1] 0 0
PART 1 (PHASE 1): Peak concentration (Cmax) of PBP1510 (µg/ml)
Timepoint [1] 0 0
Cycle (C) 1 Day (D) 1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [2] 0 0
PART 1 (PHASE 1): Time to reach Cmax (Tmax) of PBP1510 (hr)
Timepoint [2] 0 0
C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [3] 0 0
PART 1 (PHASE 1): Terminal elimination half-life (t1/2) of PBP1510 (hr)
Timepoint [3] 0 0
C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [4] 0 0
PART 1 (PHASE 1): Area under the concentration-time curve (AUC) of PBP1510 (hr*µg /ml)
Timepoint [4] 0 0
C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [5] 0 0
PART 1 (PHASE 1): Mean residence time (MRT) of PBP1510 (hr)
Timepoint [5] 0 0
C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [6] 0 0
PART 1 (PHASE 1): Volume of distribution at steady state (Vss) of PBP1510 (mL/kg)
Timepoint [6] 0 0
C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [7] 0 0
PART 1 (PHASE 1): Volume of the central compartment (Vc) of PBP1510 (mL/kg)
Timepoint [7] 0 0
C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [8] 0 0
PART 1 (PHASE 1): Clearance (CL) of PBP1510 (mL/kg/hr)
Timepoint [8] 0 0
C1D1, C1D2, C1D3, C1D5, C1D8, C1D15, C1D22, C2D1, C2D8, C2D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [9] 0 0
PART 1 (PHASE 1): Peak concentration (Cmax) of gemcitabine (µg/ml)
Timepoint [9] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days.
Secondary outcome [10] 0 0
PART 1 (PHASE 1): Time to reach Cmax (Tmax) of gemcitabine (hr)
Timepoint [10] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days.
Secondary outcome [11] 0 0
PART 1 (PHASE 1): Terminal elimination half-life (t1/2) of gemcitabine (hr)
Timepoint [11] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days.
Secondary outcome [12] 0 0
PART 1 (PHASE 1): Area under the concentration-time curve (AUC) of gemcitabine (hr*µg /ml)
Timepoint [12] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days.
Secondary outcome [13] 0 0
PART 1 (PHASE 1): Mean residence time (MRT) of gemcitabine (hr)
Timepoint [13] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days.
Secondary outcome [14] 0 0
PART 1 (PHASE 1): Clearance (CL) of gemcitabine (mL/kg/hr)
Timepoint [14] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15. Each cycle is 28 days.
Secondary outcome [15] 0 0
PART 1 (PHASE 1): Presence of anti-drug antibody (ADA) and neutralizing antibodies (NAb) against PBP1510 administered as monotherapy, and in combination with gemcitabine.
Timepoint [15] 0 0
C1D1, C1D15, C2D1, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [16] 0 0
PART 2 (PHASE 2a): Trough concentration (Ctrough) of PBP1510 (µg/ml)
Timepoint [16] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [17] 0 0
PART 2 (PHASE 2a): Peak concentration (Cmax) of PBP1510 (µg/ml)
Timepoint [17] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [18] 0 0
PART 2 (PHASE 2a): Time to reach Cmax (Tmax) of PBP1510 (hr)
Timepoint [18] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [19] 0 0
PART 2 (PHASE 2a): Terminal elimination half-life (t1/2) of PBP1510 (hr)
Timepoint [19] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [20] 0 0
PART 2 (PHASE 2a): Area under the concentration-time curve (AUC) of PBP1510 (hr*µg /ml)
Timepoint [20] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [21] 0 0
PART 2 (PHASE 2a): Mean residence time (MRT) of PBP1510 (hr)
Timepoint [21] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [22] 0 0
PART 2 (PHASE 2a): Volume of distribution at steady state (Vss) of PBP1510 (mL/kg)
Timepoint [22] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [23] 0 0
PART 2 (PHASE 2a): Volume of the central compartment (Vc) of PBP1510 (mL/kg)
Timepoint [23] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [24] 0 0
PART 2 (PHASE 2a): Clearance (CL) of PBP1510 (mL/kg/hr)
Timepoint [24] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow Up visit (90 days after last dose of PBP1510). Each cycle is 28 days.
Secondary outcome [25] 0 0
PART 2 (PHASE 2a): Trough concentration (Ctrough) of Gemcitabine (µg/ml)
Timepoint [25] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days.
Secondary outcome [26] 0 0
PART 2 (PHASE 2a): Peak concentration (Cmax) of Gemcitabine (µg/ml)
Timepoint [26] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days.
Secondary outcome [27] 0 0
PART 2 (PHASE 2a): Time to reach Cmax (Tmax) of Gemcitabine (hr)
Timepoint [27] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days.
Secondary outcome [28] 0 0
PART 2 (PHASE 2a): Terminal elimination half-life (t1/2) of Gemcitabine (hr)
Timepoint [28] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days.
Secondary outcome [29] 0 0
PART 2 (PHASE 2a): Area under the concentration-time curve (AUC) of Gemcitabine (hr*µg /ml)
Timepoint [29] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days.
Secondary outcome [30] 0 0
PART 2 (PHASE 2a): Mean residence time (MRT) of Gemcitabine (hr)
Timepoint [30] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days.
Secondary outcome [31] 0 0
PART 2 (PHASE 2a): Clearance (CL) of Gemcitabine (mL/kg/hr)
Timepoint [31] 0 0
C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1, C4D8, C4D15. Each cycle is 28 days.
Secondary outcome [32] 0 0
PART 2 (PHASE 2a): Progression-free survival (PFS) after treatment with PBP1510 administered in combination with gemcitabine
Timepoint [32] 0 0
From the first PBP1510 infusion to date of first documentation of progressive disease or death from any cause, through study completion (approximately 1 year)
Secondary outcome [33] 0 0
PART 2 (PHASE 2a): Overall Survival (OS) after treatment with PBP1510 administered in combination with gemcitabine
Timepoint [33] 0 0
From the first PBP1510 infusion to the date of death due to any cause, through study completion (approximately 1 year)
Secondary outcome [34] 0 0
PART 2 (PHASE 2a): Duration of Response (DoR) after treatment with PBP1510 administered in combination with gemcitabine
Timepoint [34] 0 0
from the first documentation of overall response (CR or PR) post first PBP1510 infusion to the first documentation of disease progression or death from any cause, through study completion (approximately 1 year)
Secondary outcome [35] 0 0
PART 2 (PHASE 2a): Presence of ADA and NAb against PBP1510 administered in combination with gemcitabine.
Timepoint [35] 0 0
C1D1, C2D1, C3D1, C4D1, End of Treatment visit (28 days after last dose of PBP1510) and Safety Follow-up visit (90 days after last dose of PBP1510). Each cycle is 28 days.

Eligibility
Key inclusion criteria
Patients enrolling into Part 1 (Phase 1), or Part 2 (Phase 2a) must meet all of the following inclusion criteria:

1. Adults = 18 years of age (or the legal age of majority in the country of recruitment) at the time consent is obtained.
2. Patient should understand, voluntarily sign, and date the written consent form prior to any protocol-specific procedures.
3. Performance Status score less than or equal to 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
4. Have histological or cytological evidence of a diagnosis of pancreatic cancer that is advanced and/or metastatic.
5. Have a life expectancy of = 3 months.
6. No other malignancy present that would interfere with the current intervention.
7. Prior radiation therapy for treatment of cancer is allowed to < 25% of the bone marrow, and patients must have recovered from the acute toxic effects of their treatment prior to study enrolment. Prior radiotherapy must be completed at least 4 weeks before the first dose of study treatment.
8. At least one measurable lesion as per RECIST v1.1
9. Adequate baseline organ function defined as:

ANC = 1.5 × 10^9 /L; Haemoglobin = 9 g/dL; Platelets = 100 × 10^9 /L; Total bilirubin = 2 × ULN (= 3 x ULN for patients with biliary stenting and patients with Gilbert's syndrome); AST and ALT < 3 x ULN (= 5 x ULN for patients with hepatic metastases); Serum creatinine OR creatinine clearance (as determined by the Cockcroft Gault formula) OR eGFR based on MDRD = 1.5 x ULN OR = 50 mL/min OR = 50 mL/min/1.73 m^2; LVEF = 50% by ECHO or MUGA; QTc = 470 ms
10. Female patients of nonchildbearing potential must meet at least 1 of the following criteria: have undergone a documented hysterectomy, and/or bilateral oophorectomy; have medically confirmed ovarian failure or achieved postmenopausal status. A postmenopausal state is defined as cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a follicle stimulating hormone (FSH) level confirming the postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. Female patients of childbearing potential must have a negative serum pregnancy test within 28 days prior to and negative urine pregnancy test just prior to the first dose of PBP1510 and agree to use effective contraception, in accordance with the recommendations of the Clinical Trials Facilitation and Coordination Group (CTFG) from study entry and until for at least 6 months after the last dose of PBP1510.
11. For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) from study entry and until for at least 6 months after the last dose of PBP1510.

Investigator or his/her representative should discuss acceptable pregnancy prevention method(s) with the patients. Highly effective methods of birth control include those that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, levonorgestrel-releasing intrauterine system, intra-uterine devices (IUDs), and true sexual abstinence.
12. Patients must be willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.

Patients enrolling into Part 1 (Phase 1) of the study must also meet the following inclusion criteria:
13. Monotherapy and combination cohorts: advanced/metastatic pancreatic cancer patients whose tumours have progressed after at least one prior line of standard chemotherapy.

Patients enrolling into Part 2 (Phase 2a) of the study must also meet the following inclusion criteria:
14. Advanced/metastatic pancreatic cancer patients whose tumours have progressed after one prior line of standard chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients enrolling into Part 1 (Phase 1), or Part 2 (Phase 2a) will be excluded if any of the following criteria apply:

1. Patients who have known brain metastases will be excluded from the study. However, a patient may be included in the study, if has been previously treated for brain metastasis, the disease is well controlled for at least 3 months, and the patient is off steroids.
2. Patients who have undergone a major surgery within 4 weeks prior to the start of PBP1510 administration, other than endoscopic/radiation procedures, bypass surgery (i.e., gastrojejunostomy), laparoscopy, port placement or a diagnostic surgery (i.e., surgery done to obtain a diagnostic biopsy, without removal of an organ), as long as the patient has recovered from these minor surgical procedures.
3. Patients who have active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, e.g., an active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii (P. carinii), or other microorganisms that is under treatment with myelotoxic drugs.
4. Patient has a known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
5. Patient has known history of or currently active hepatitis B (e.g., hepatitis B antigen [HBsAg] reactive), hepatitis C (e.g., HCV RNA [qualitative] is detected) or syphilis [Venereal Disease Research Laboratory (VDRL) to detect antibodies in blood]).
6. Patient has impaired cardiac function and uncontrolled cardiac diseases/hypertension that are deemed clinically significant by the Investigator and which could compromise the patient's safety or the study data integrity.
7. Patient has serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
8. Any other malignancy from which the patient has been disease-free for less than 5 years, except for adequately treated and cured basal or squamous cell skin cancer.
9. Patients who are enrolled in any other therapeutic clinical trial.
10. Patients currently receiving radiation therapy or those having received radiation within 4 weeks prior to study entry.
11. Patients having received investigational anti-cancer drug within 28 days (or 5 half-lives, whichever is longer) preceding the first dose of PBP1510 or chemotherapy within the last 4 weeks prior to the first dose of PBP1510.
12. Patients with known allergy or hypersensitivity to components of the PBP1510 formulation including the excipients and history of hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
13. Patients who are pregnant, or breast feeding.
14. Patients who are unwilling or unable to comply with study procedures.
15. Patients who are not eligible to participate in this study, as judged by Investigators.
16. A history of allergic reactions attributed to gemcitabine or compounds of similar chemical composition to gemcitabine and/or previous treatment discontinuation due to gemcitabine toxicity.

Note: Patients with previous exposure to gemcitabine should not be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore
Country [3] 0 0
Spain
State/province [3] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prestige Biopharma Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mei Li Lim
Address 0 0
Country 0 0
Phone 0 0
+65-6924-6535
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05141149