Metastatic Castration-Resistant Prostate Cancer (mCRPC)Phase 1NCT03074032
Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer
A Phase 1 study testing ONC1-0013B in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Avionco LLC at 2 sites in Russia.
Trial summary
This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be escalated to the next doses with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- What is being tested?
- ONC1-0013B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesRussia
- Study dates
- 30 Jun 2014to Apr 2017
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 18 years and older.
- Histologically confirmed diagnosis of prostate cancer
- Castrate level of testosterone in blood serum < 1,7 nmol/l or < 50 ng/dl
- PSA level at screening > 2 ng/ml
- Progression of metastatic CRPC after the chemical castration with gonadotropin-releasing hormone (GnRH) analogue or after the chemical castration and subsequent chemotherapy.
- The patient's ECOG performance status of 0 - 2
- Patients previously treated with docetaxel chemotherapy should have received 2 or less prior lines of chemotherapy for mCRPC
- The expected survival time of not less than 12 weeks
Who cannot join
- Prior anticancer therapy:
- Treatment with chemotherapeutic agents or radiotherapy within 4 weeks prior to screening or preserved toxicities of ≥ II grade according to CTCAE scale, related to prior anticancer therapy (excluding alopecia)
- Prior antiandrogen therapy: flutamide within 4 weeks prior to screening or bicalutamide within 6 weeks prior to screening
- Exposure to bisphosphonates is allowed only if the treatment started prior to screening
- Clinically significant cardiovascular system diseases:
- Clinically significant central nervous system diseases:
Show all 11Show fewer
- History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus)
- Prior or concomitant therapy:
- Exposure to drugs which may cause a convulsive state within 4 weeks prior to screening
- Exposure to treatment with characteristics of CYP3A4 or CYP2D6 inhibitors within 4 weeks prior to screening
- Exposure to treatment relating to the Class I risk of QT-interval prolongation; exposure to treatment relating to the Class II risk of QT-interval prolongation is allowed if the patient have received not less than 5 half-life periods of flat-dosed treatment
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Research Institute of Urology and Interventional Radiology n.a. N.A. Lopatkin (branch of FSBI NMRRC of the Ministry of Health of the Russian Federation)
Moscow, 105426
Medical Radiological Research Center n.a. A.F. Tsyb (branch of FSBI NMRRC of the Ministry of Health of the Russian Federation)
Obninsk, 249036
About this study
Official title: Phase I Open-label Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer (mCRPC)
This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be escalated to the next doses with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients. Tumor assessment and PSA values will be evaluated during the study as an additional point.
- Being tested
- ONC1-0013B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONC1-0013BDrug
ONC1-0013B per os daily
| Study group | Role | What they receive |
|---|---|---|
| ONC1-0013B 40 mg | Experimental | ONC1-0013B 40 mg per os daily Receives: Drug: ONC1-0013B |
| ONC1-0013B 80 mg | Experimental | ONC1-0013B 80 mg per os daily Receives: Drug: ONC1-0013B |
| ONC1-0013B 160 mg | Experimental | ONC1-0013B 160 mg per os daily Receives: Drug: ONC1-0013B |
| ONC1-0013B 320 mg | Experimental | ONC1-0013B 320 mg per os daily Receives: Drug: ONC1-0013B |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT within 4 weeks of ONC1-0013B administration (safety and tolerability)
Incidence rate and severity of adverse events, changes in laboratory tests
Measured: 4 weeks and during the study up to 76 weeks
Secondary outcomes (6)
Peak Plasma Concentration (Cmax)
PK analysis of ONC1-0013B after single and multiple dosage
Measured: 28 days
Area under the plasma concentration versus time curve (AUC)
PK analysis of ONC1-0013B after single and multiple dosage
Measured: 28 days
Elimination half-life (T1/2)
PK analysis of ONC1-0013B after single and multiple dosage
Measured: 28 days
Time-to-peak concentration (tmax)
PK analysis of ONC1-0013B after single and multiple dosage
Measured: 28 days
Steady-State Concentration (Css)
PK analysis of ONC1-0013B after single and multiple dosage
Measured: 28 days
Tumor response
RECIST 1.1 criteria and the change of the PSA level
Measured: 12 weeks and during the study up to 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start30 Jun 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)Studies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avionco LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074032
- Sponsor's protocol ID
- ONC-ONC10013B-01
- Status last verified
- Jul 2017
- First submitted
- 3 Mar 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open-label Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT03074032
- Acronym / sponsor ID
- ONC-ONC10013B-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Avionco LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be escalated to the next doses with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients. Tumor assessment and PSA values will be evaluated during the study as an additional point.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| ONC1-0013B 40 mg | Experimental | Drug: ONC1-0013BONC1-0013B 40 mg per os daily |
| ONC1-0013B 80 mg | Experimental | Drug: ONC1-0013BONC1-0013B 80 mg per os daily |
| ONC1-0013B 160 mg | Experimental | Drug: ONC1-0013BONC1-0013B 160 mg per os daily |
| ONC1-0013B 320 mg | Experimental | Drug: ONC1-0013BONC1-0013B 320 mg per os daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men aged 18 years and older.
- Histologically confirmed diagnosis of prostate cancer
- Castrate level of testosterone in blood serum < 1,7 nmol/l or < 50 ng/dl
- PSA level at screening > 2 ng/ml
- Progression of metastatic CRPC after the chemical castration with gonadotropin-releasing hormone (GnRH) analogue or after the chemical castration and subsequent chemotherapy.
Key exclusion criteria (11 listed)
- Prior anticancer therapy:
- Clinically significant cardiovascular system diseases:
- Clinically significant central nervous system diseases:
- History of other significant concomitant diseases which, in the Investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus)
- Prior or concomitant therapy:
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 |
|---|---|---|
| ONC1-0013BONC1-0013B per os daily | Drug | ONC1-0013B 160 mg, ONC1-0013B 320 mg, ONC1-0013B 40 mg, ONC1-0013B 80 mg |
Primary outcome
DLT within 4 weeks of ONC1-0013B administration (safety and tolerability)
Time frame: 4 weeks and during the study up to 76 weeks
Incidence rate and severity of adverse events, changes in laboratory tests
6 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: 28 days
Area under the plasma concentration versus time curve (AUC)
Time frame: 28 days
Elimination half-life (T1/2)
Time frame: 28 days
Time-to-peak concentration (tmax)
Time frame: 28 days
Steady-State Concentration (Css)
Time frame: 28 days
Tumor response
Time frame: 12 weeks and during the study up to 76 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONC1-0013B in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC), run by Avionco LLC at 2 sites in Russia.
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 8 inclusion and 11 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DLT within 4 weeks of ONC1-0013B administration (safety and tolerability) (time frame: 4 weeks and during the study up to 76 weeks). 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 11 Jul 2017.