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Prostatic Cancer, Castration-ResistantPhase 1PROSTIRNANCT02866916

Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer (PROSTIRNA)

A Phase 1 study testing SXL01 in people with Prostatic Cancer, Castration-Resistant, run by Institut Claudius Regaud at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a single site, open-label, non-randomized, dose escalation phase I study designed to evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger RNA (mRNA), in patients with metastatic… Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostatic Cancer, Castration-Resistant
What is being tested?
SXL01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteFrance
Study dates
Sep 2017to Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males age 18-80 years.
  • ECOG performance status 0 - 1.
  • Life expectancy of more than 3 months.
  • Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell feature.
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy.
  • Detectable metastases by bone scan, CT scan or MRI.
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  • Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with LHRH agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study.
  • Documented prostate cancer progression as assessed by the investigator with one of the following:
  • 8.1. PSA progression defined by a minimum of two raising PSA levels with an interval of >1 week between each determination. The PSA values at the screening visit must be ≥ 1 µg/l (1 ng/mL).
  • 8.2. Radiographic progression of soft tissue disease by modified RECIST criteria 1.1 or of bone metastasis with two or more documented new bone lesions on a bone scan with or without PSA progression.
  • Adequate hepatic, renal, and hematologic function: AST/ALT ≤ 2.5 X ULN; Normal bilirubin or ≤ 1.5 ULN in case of Gilbert's syndrome; Serum creatinine CL> 60 mL/min by the Cockcroft-Gault formula; Hemoglobin ≥ 10 g/dL; Absolute neutrophil count ≥ 1500/mm3, Platelet count ≥ 100,000/mm3.
  • Patients must have recovered from the toxic effects of prior therapy (except alopecia) to NCIC CTCAE version 4.03 grade ≤1 and to baseline laboratory values as defined in inclusion criteria 9.
  • If sexually active, willing to use barrier contraception during the treatment phase of the protocol.
  • Written informed consent and any locally required authorization (e.g., Social security for France (Health Insurance)) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
  • Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • BMI ≥ 30.
  • Evidence of brain metastasis.
  • Patient seropositive for HIV and/or hepatitis B antigen positive and/or Hepatitis C antibody.
  • Patient with history of autoimmune disease with the exception of vitiligo, psoriasis and controlled diabetes.
  • Active suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, irritable bowel syndrome, Wegener's granulomatosis and Hashimoto's thyroiditis).
  • Patient with history of another malignancy, except for the following: skin cancers (melanoma excluded), previously treated cancer with no sign of disease for at least 3 years.
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  • Patient with concurrent infection or concurrent chronic or acute illness such as pulmonary (asthma or COPD), cardiac (NYHA class III or IV) or hepatic disease, or other illness considered by the principal investigator to constitute an unwarranted high risk for investigational drug administration will be excluded.
  • Patient who has got a medical condition contraindicated for subcutaneous administration.
  • Chronic systemic corticosteroid use within 4 weeks of the first administration of SXL01 (more than 2 weeks for a dose > 0.5 mg/kg of prednisolone).
  • Treatment with any hormonal therapy or androgen antagonist, including flutamide, bicalutamide, nilutamide, ketoconazole, diethylstilbestrol, Abiraterone, or enzalutamide, within 4 weeks of the first administration with the exception of GnRH agonists.
  • Patients requiring a continuous curative anti-coagulant treatment.
  • Patients requiring a continuous bisphosphonate or denosumab treatment at inclusion. Note: the use of bisphosphonate and denosumab during the course of the study will be allowed.
  • Planned to initiate any other anti-tumor therapies during the study.
  • Radiation therapy or surgery within 4 weeks of the first administration of SXL01.
  • Mental impairment (psychiatric illness/social situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study.
  • Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Claudius Regaud

    Toulouse, 31059

Other trials in France

About this study

Official title: Phase I Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer

This is a single site, open-label, non-randomized, dose escalation phase I study designed to evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger RNA (mRNA), in patients with metastatic castration-resistant prostate cancer.

A standard method "3+3" will be used for dose escalation. A maximum of 30 patients will complete the dose-escalation phase of the study; 12 additional patients will be included at the RP2D in the expansion phase.

Being tested
SXL01
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SXL01Drug

    Treatment will be administered continuously over 24h through the subcutaneous route.

Study groups in NCT02866916
Study groupRoleWhat they receive
Dose escalationExperimentalThe standard method "3+3" will be used for dose escalation: the first 3 patients will be treated at level 1; consecutive cohorts of 3 to 6 patients will be treated with increasing doses of SXL01. Treatment will be administered until patient experiences unacceptable toxicity, PSA raising, progressive disease and/or treatment is discontinued at the discretion of the investigator or withdrawal of consent. Additional patients will be included at the Recommended Phase II Dose (RP2D) in the expansion phase.
Receives: Drug: SXL01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of Dose Limiting Toxicities (DLT) during the first cycle of treatment with SXL01.

    Measured: 25 months

  2. Characteristics of Dose Limiting Toxicities (DLT) during the first cycle of treatment with SXL01.

    Measured: 25 months

  3. Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Tolerability and safety will be assessed through recording of adverse events using National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) toxicity classification, monitoring biological parameters and vital signs measurement.

    Measured: 33 months

Secondary outcomes (3)

  1. Preliminary efficacy endpoint : rate of patients presenting Prostate Specific Antigen (PSA) progression defined using Prostate Cancer Clinical Trial Working Group 3 (PCWG3)

    Measured: 33 months

  2. Preliminary efficacy endpoint : rate of patients presenting clinical or radiological progression using Response Evaluation Criteria in Solid Tumours (RECIST) V1.1 as defined by PCWG3.

    Measured: 33 months

  3. Pharmacokinetics - SXL01 plasma concentration

    Measured: Cycle 1: pre-dose (T0) then 0.5, 3, 6, 24 hours post dose on day 1 ; T0 on days 4, 8, 15, 22. Subsequent cycles : before administration on day 1 (CXD1). The day of treatment discontinuation (CXDX) : 0.5, 1, 2, 24 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study startSep 2017 (estimated)
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Why it stopped: Study cancelled

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866916
Sponsor's protocol ID
16GENH01
Acronym
PROSTIRNA
Status last verified
Nov 2016
First submitted
8 Aug 2016
Last updated
20 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SXL01 in people with Prostatic Cancer, Castration-Resistant, run by Institut Claudius Regaud at 1 site in France.

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 15 inclusion and 16 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: withdrawn, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence rate of Dose Limiting Toxicities (DLT) during the first cycle of treatment with SXL01. (time frame: 25 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866916.

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 20 Jan 2021.

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