Stage III Prostate CarcinomaPhase 1/2VAL201-001NCT02280317
Dose Finding Safety Study of VAL201 in Cancer Patients
A Phase 1/2 study testing VAL201 in people with Stage III Prostate Carcinoma and Stage IV Prostate Carcinoma, run by ValiRx Plc.
Trial summary
Dose finding safety study of VAL201 in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage III Prostate Carcinoma, Stage IV Prostate Carcinoma
- What is being tested?
- VAL201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to 27 Jan 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- Absent or very mild prostate cancer-related symptoms.
- 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informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.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.
Who cannot join
- 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.
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- 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.
About this study
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
Dose finding safety study of VAL201 in cancer patients.
Read the 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.
- Being tested
- VAL201
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAL201Drug
Also called VAL201-001
VAL201-001 Sub-cutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 0.5 mg/kg | Experimental | VAL201-001 Sub-cutaneous injection. 0.5 mg/kg Receives: Drug: VAL201 |
| Cohort 2: 1 mg/kg | Experimental | VAL201-001 Sub-cutaneous injection. 1.0 mg/kg Receives: Drug: VAL201 |
| Cohort 3: 2 mg/kg | Experimental | VAL201-001 Sub-cutaneous injection. 2.0 mg/kg Receives: Drug: VAL201 |
| Cohort 4: 4 mg/kg | Experimental | VAL201-001 Sub-cutaneous injection. 4.0 mg/kg Receives: Drug: VAL201 |
| Cohort 5: up to 8 mg/kg | Experimental | 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. Receives: Drug: VAL201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity
The number of Dose-Limiting Toxicity events is used to determine whether a maximum tolerated dose (MTD) is obtained.
Measured: The average timeframe is 18-26 weeks per subject
Secondary outcomes (2)
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.
Measured: The average timeframe is 18-26 weeks per subject
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.
Measured: The average timeframe is 18-26 weeks per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage III Prostate CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose Escalation sequential assignment
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ValiRx Plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280317
- Sponsor's protocol ID
- VAL201-001
- Other IDs
- 2013-004009-25
- Acronym
- VAL201-001
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2014
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02280317
- Acronym / sponsor ID
- VAL201-001 / VAL201-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ValiRx PlcIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 8 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Dose Escalation sequential assignment
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 0.5 mg/kg | Experimental | Drug: VAL201VAL201-001 Sub-cutaneous injection. 0.5 mg/kg |
| Cohort 2: 1 mg/kg | Experimental | Drug: VAL201VAL201-001 Sub-cutaneous injection. 1.0 mg/kg |
| Cohort 3: 2 mg/kg | Experimental | Drug: VAL201VAL201-001 Sub-cutaneous injection. 2.0 mg/kg |
| Cohort 4: 4 mg/kg | Experimental | Drug: VAL201VAL201-001 Sub-cutaneous injection. 4.0 mg/kg |
| Cohort 5: up to 8 mg/kg | Experimental | Drug: VAL201VAL201-001 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Specific Inclusion Criteria for Patients with Other Advanced Solid Tumours
Key exclusion criteria (9 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAL201Also: VAL201-001VAL201-001 Sub-cutaneous injection. | Drug | Cohort 1: 0.5 mg/kg, Cohort 2: 1 mg/kg, Cohort 3: 2 mg/kg, Cohort 4: 4 mg/kg, Cohort 5: up to 8 mg/kg |
Primary outcome
Dose-Limiting Toxicity
Time frame: 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.
2 secondary outcomes
Pharmacokinetics of VAL201. (Cmax)
Time frame: The average timeframe is 18-26 weeks per subject
Pharmacokinetics of VAL201 (AUC 0-inf)
Time frame: The average timeframe is 18-26 weeks per subject
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Prostatic Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VAL201 in people with Stage III Prostate Carcinoma and Stage IV Prostate Carcinoma, run by ValiRx Plc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (time frame: The average timeframe is 18-26 weeks per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.