Dose Finding Safety Study of VAL201 in Cancer Patients

NCT ID: NCT02280317

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2020-01-27

Brief Summary

Dose finding safety study of VAL201 in cancer patients.

Detailed 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.

Conditions

Stage III Prostate Carcinoma; Stage IV Prostate Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: 0.5 mg/kg

VAL201-001 Sub-cutaneous injection. 0.5 mg/kg

Group Type: EXPERIMENTAL

VAL201

Intervention Type: DRUG

VAL201-001 Sub-cutaneous injection.

Cohort 2: 1 mg/kg

VAL201-001 Sub-cutaneous injection. 1.0 mg/kg

Group Type: EXPERIMENTAL

VAL201

Intervention Type: DRUG

VAL201-001 Sub-cutaneous injection.

Cohort 3: 2 mg/kg

VAL201-001 Sub-cutaneous injection. 2.0 mg/kg

Group Type: EXPERIMENTAL

VAL201

Intervention Type: DRUG

VAL201-001 Sub-cutaneous injection.

Cohort 4: 4 mg/kg

VAL201-001 Sub-cutaneous injection. 4.0 mg/kg

Group Type: EXPERIMENTAL

VAL201

Intervention Type: DRUG

VAL201-001 Sub-cutaneous injection.

Cohort 5: up to 8 mg/kg

VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.

Group Type: EXPERIMENTAL

VAL201

Intervention Type: DRUG

VAL201-001 Sub-cutaneous injection.

Interventions

VAL201

VAL201-001 Sub-cutaneous injection.

Intervention Type: DRUG

Other Intervention Names

VAL201-001

Eligibility Criteria

Inclusion Criteria

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

• 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.

• 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

• Any patients who have undergone prior orchidectomy.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ValiRx Plc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2013-004009-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAL201-001

Identifier Type: -

Identifier Source: org_study_id