Dose Finding Safety Study of VAL201 in Cancer Patients

Phase 1

Completed

• Conditions: Stage III Prostate Carcinoma; Stage IV Prostate Carcinoma
• Interventions: Drug: VAL201

• Registration Number: NCT02280317
• Lead Sponsor: ValiRx Plc

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-31
• Primary Completion: 2020-01-27
• Study Completion: 2020-01-27
• Results First Submitted: 2021-03-31
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Results First Posted: 2021-11-08
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 4: 4 mg/kg	VAL201	VAL201-001 Sub-cutaneous injection. 4.0 mg/kg
Cohort 1: 0.5 mg/kg	VAL201	VAL201-001 Sub-cutaneous injection. 0.5 mg/kg
Cohort 2: 1 mg/kg	VAL201	VAL201-001 Sub-cutaneous injection. 1.0 mg/kg
Cohort 3: 2 mg/kg	VAL201	VAL201-001 Sub-cutaneous injection. 2.0 mg/kg
Cohort 5: up to 8 mg/kg	VAL201	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.

Primary Outcome Measures

Name	Time	Method
Dose-Limiting Toxicity	The average timeframe is 18-26 weeks per subject	The number of Dose-Limiting Toxicity events is used to determine whether a maximum tolerated dose (MTD) is obtained.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of VAL201. (Cmax)	The average timeframe is 18-26 weeks per subject	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.
Pharmacokinetics of VAL201 (AUC 0-inf)	The average timeframe is 18-26 weeks per subject	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.