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 - Dose finding safety study of VAL201 in cancer patients

ValiRx plc0 sites81 target enrollmentFebruary 9, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 9, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•(i) Specific Inclusion Criteria for Patients with Prostate Cancer
•1\. Patients with incurable, locally advanced or metastatic prostate cancer who have relapsed following radiotherapy treatment, are in ‘watchful waiting’ or where a policy of intermittent hormone therapy has been decided. These patients must also have the following:
•a. rising PSA on three samples; each over 2 weeks apart, with the values being greater than 2 ng/mL higher than and at least 25% over the nadir.
•b. absent or very mild prostate cancer\-related symptoms
•c. no plans for any therapy for prostate cancer in the next two months.
•2\. Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) of \= 1
•3\. Age \=18 years at time of consent.
•(ii) Specific Inclusion Criteria for Patients with Other Advanced Solid Tumours
•4\. 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 e.g. fibrosarcoma, ovarian cancer.
•5\. Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) of \= 2

•(i) Specific Exclusion Criteria for Patients with Prostate Cancer
•Patients has received:
•1\. an anti\-cancer therapy, including investigational agents, within 6 weeks of Cycle 1, Day 1;
•2\. Patients who have undergone prior orchidectomy.
•(ii) Specific Exclusion Criteria for Patients with Other Advanced Solid Tumours
•3\. Patients has received:
•a) any chemotherapy regimens (including investigational agents) with delayed toxicity within 4 weeks (6 weeks for prior nitrosourea or mitomycin C) of Cycle 1, Day 1, or received chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks of Cycle 1, Day 1\.
•b) radiotherapy, immunotherapy or biological agents (includes investigational agents) within 4 weeks of Cycle 1, Day 1\. Localised palliative radiotherapy is permitted for symptom control.
•4\. Pregnant or lactating female patients.
•(iii) General Exclusion Criteria for all Patients