Dose Finding Safety Study of VAL201 in Cancer Patients

Stage III Prostate Carcinoma Clinical Trial

— VAL201-001  

Official title:

A Phase I/II, Dose Escalation Study To Assess The Safety and Tolerability of VAL201 In Patients With Advanced or Metastatic Prostate Cancer and Other Advanced Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280317
• Other study ID #: VAL201-001
• Secondary ID: 2013-004009-25
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2014
• Est. completion date: January 27, 2020

Study information

• Verified date: October 2021
• Source: ValiRx Plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dose finding safety study of VAL201 in cancer patients.

Description:

A Phase I/II, dose escalation study to assess the safety and tolerability of VAL201 in patients with locally advanced or metastatic prostate cancer and other advanced solid tumours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 27, 2020
• Est. primary completion date: January 27, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

The study will enrol patients with locally advanced or metastatic prostate cancer. The MTD/MAD may also be evaluated in patients with other advanced tumour types for whom no standard effective therapy is available and a rationale for use of VAL201 exists.

The average timeframe is 18-26 weeks per subject and the outcome measured is a composite average for each group.

• Inclusion criteria:

• Specific Inclusion Criteria for Patients with Prostate Cancer

• Patients with incurable, locally advanced or metastatic prostate cancer where a policy of intermittent hormone therapy has been decided. Who have specific clinical parameters.

• Specific Inclusion Criteria for Patients with Other Advanced Solid Tumours

• Patients with histologically and/or cytologically confirmed advanced solid tumour for whom no standard effective therapy is available and a rationale for use of VAL201 exists.

• Patients with incurable, locally advanced or metastatic prostate cancer where a policy of intermittent hormone therapy has been decided. These patients must also have the following:

1. Rising PSA on three samples (once non-castrate levels established); each over 2 weeks apart, with the last two values being greater than 2 ng/mL. Higher than and at least 25% over the nadir.

2. Absent or very mild prostate cancer-related symptoms.

3. No plans for any therapy for prostate cancer in the next two months.

• General Inclusion Criteria for all Patients

• Adult patients defined by age greater than 18 years at time of consent.

• Ability to give written, informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.

• Patient is capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.

• Evaluable disease, either measurable on imaging, or with informative tumour marker(s) and a set of specific biochemical and haematological parameters relating to the specific cancer.

• Negative human chorionic gonadotropin (hCG) test in women of childbearing potential.

• Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control. Female patients may be surgically sterile.

• Laboratory values at Screening:

• Absolute neutrophil count =1.5 x 109/L.

• Platelets =100 x 109/L.

• Haemoglobin =9 g/dL without blood transfusion or colony stimulating factor support.

• Total bilirubin <1.5 times the upper limit of normal (ULN);

• AST (SGOT) =2.5 times the ULN;

• ALT (SGPT) =2.5 times the ULN; =5 x ULN for patients with advanced solid tumours with liver metastases.

• Serum creatinine =1.5 x ULN or estimated glomerular filtration rate (GFR) of >50 mL/min based on the Cockcroft-Gault formula.

• Exclusion criteria

• Specific Exclusion Criteria for Patients with Prostate Cancer Patients has received an anticancer therapy, including investigational agents, within the precious 6 weeks or 4 weeks.

• Any patients who have undergone prior orchidectomy.

• Specific Exclusion Criteria for Patients with Other Advanced Solid Tumours Pregnant or lactating female patients.

• Documented, symptomatic or uncontrolled brain metastases.

• History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months previous to the indication of home therapy.

• Known Human Immunodeficiency Virus positivity.

• Active Hepatitis B or C or other active liver disease (other than malignancy).

• Any active, clinically significant, viral, bacterial, or systemic fungal infection within previous 4 weeks prior to home therapy.

• Any medical history that would jeopardize compliance.

Related Conditions & MeSH terms

• Carcinoma
• Prostatic Neoplasms
• Stage III Prostate Carcinoma
• Stage IV Prostate Carcinoma

Intervention

Drug:
• VAL201
VAL201-001 Sub-cutaneous injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ValiRx Plc

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients Who Completed 6 Cycles of Treatment	The number of patients who completed 6 cycles of treatment is compared with the number who withdrew prior to completion of the scheduled 6 cycles	The average timeframe is 18-26 weeks per subject
Other	Number of Patients Displaying Disease Progression by PCWG2 and/or RECIST Criteria	Assessment of disease response to treatment by PCWG2 and/or RECIST. Disease progression is defined by RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; and by PCWG2 criteria that PSA values did not see an increase of 25% or more and absolute increase of 2 ng/mL or more from the nadir.	The average timeframe is 18-26 weeks per subject
Primary	Dose-Limiting Toxicity	The number of Dose-Limiting Toxicity events is used to determine whether a maximum tolerated dose (MTD) is obtained.	The average timeframe is 18-26 weeks per subject
Secondary	Pharmacokinetics of VAL201. (Cmax)	Assessment of pharmacokinetic variables at multiple time points (5 min, 10 min, 15 min, 30 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after dosing) and multiple dosing days (Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 6 Day 1) for each patient analysed.	The average timeframe is 18-26 weeks per subject
Secondary	Pharmacokinetics of VAL201 (AUC 0-inf)	Assessment of pharmacokinetic variables at multiple time points (5 min, 10 min, 15 min, 30 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after dosing) and multiple dosing days (Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 6 Day 1) for each patient analysed.	The average timeframe is 18-26 weeks per subject