Castration Resistant Prostate CancerPhase 1NCT02502994
Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC
A Phase 1 study testing GEN0101 in people with Castration Resistant Prostate Cancer, run by Norio Nonomura at 1 site in Japan.
Trial summary
This study is designed to evaluate the safety and efficacy of a single injection of GEN0101 in patients with recurrence of castration resistant prostate cancer. The subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and followed subcutaneous injection) and two weeks of observation as… Read more about this study
- Who is it for?
- Ages 20 to 85 years, men only
- Conditions the study is for
- Castration Resistant Prostate Cancer
- What is being tested?
- GEN0101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- May 2015to Dec 2016
- 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 20 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients providing a written informed consent by voluntary agreement.
- Age 20 =< and =<85 years old at the time of informed consent
- Have a diagnosis of malignant tumor as confirmed by histology or cytology.
- Have a diagnosis of recurrence of castration resistant prostate cancer and meet the following condition
- Inapplicable to the standard treatment, ineffective through the criteria of the Prostate Cancer Clinical Trials Working Group (PCWG2) or refuse the standard treatment
- More than 6 week between the end date of the standard treatment and the registration date when the standard treatment has been ineffective
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- Serum PSA <100 ng/mL at the screening visit
- Expected survival period is more than 8 weeks after planned start date of investigational product
- ECOG Performance Status 0 or 1
- Have an injectable intraprostatic lesion confirmed by histologic examination
- The marrow function, liver function and the kidney function must be kept as follows at the screening visit (1) leukocyte >= 3,000/mcL (2) neutrophil >=1,500/mcL (3) platelet >=75,000/mcL (4) hemoglobin >=8.0 g/dL. (5) AST =<100 IU/L (6) ALT =<100 IU/L (7) total bilirubin =<2.5 mg/dL (8) serum creatinine =<2.5 mg/dL
Who cannot join
- Have multiple brain metastases
- Positive result of the prick test of GEN0101
- Have serious complications such as uncontrolled active infection
- Received systemic chemotherapy, radiotherapy or immunotherapy within 6 weeks before the planned registration date However the hormone therapy except for the estramustine, enzalutamide and abiraterone, bisphosphonate and anti-RANKL antigen antibody is are not included in the systemic chemotherapy.
- Received another investigational medical product within 4 weeks before the informed concent
- Had a history of malignancy other than prostate cancer, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration
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- Have an active autoimmune disease
- Receiving systemic administration of glucocorticosteroid which restrains immunity response, except for the administration for a long period (over 6 months) of the low dose (equivalent to under 10 mg/day oral prednisolone).
- Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication)
- PT(%) less than 10% of the lower limit of normal or APTT more than 1.5 times of the upper limit of normal of local reference range at the screening visit
- Positive result of the hepatitis B surface antigen, HCV antibody or HIV test at the screening visit
- Inappropriate to be enrolled in this study judged by the investigators
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Urology, Osaka University Hospital
Suita, Osaka, 565-0871
About this study
Official title: Phase 1 Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral and Subcutaneous Administration of GEN0101 in Patients With Recurrence of Castration Resistant Prostate Cancer
This study is designed to evaluate the safety and efficacy of a single injection of GEN0101 in patients with recurrence of castration resistant prostate cancer.
The subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and followed subcutaneous injection) and two weeks of observation as one cycle treatment period. Each subject receive two cycle treatment period.
Low dose group: 30,000m NAU per injection of GEN0101 High dose group: 60,000m NAU per injection of GEN0101 Each group included minimal 3 subjects.
- Conditions
- Castration Resistant Prostate Cancer
- Being tested
- GEN0101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN0101Drug
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Single arm of the castration resistant prostate cancer Receives: Drug: GEN0101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT (Dose Limiting Toxicity)
To determine the appropriate dosing strategy for GEN0101 for castration resistant prostate cancer
Measured: 8 weeks
Secondary outcomes (4)
Number of participants with tumor shrinkage according to the RECIST.
Measured: 8 weeks
Change from baseline in tumor marker (PSA: Prostate Specific Antigen, NSE: Neuron-specific enolase, CEA: Carcinoembryonic Antigen, and CA19-9: Carbohydrate Antigen19-9) at Cycle 1, Week 4 and at Cycle 2, Week 4.
Measured: 8 weeks
Change from baseline in prostate histological evaluation at Cycle2, Week2.
Measured: 8 weeks
Change from baseline in induction of antitumor immunity (NK cell activity, IL-6 and IFN-gamma) at Cycle1, Week 2 and Week 4 and at Cycle2, Week 2 and Week 4.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration Resistant Prostate CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norio Nonomura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Norio Nonomura, Osaka University
- Investigators
- Norio Nonomura, MD, Study chair, Urology, Osaka University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502994
- Sponsor's protocol ID
- GEN0101-JM002
- Status last verified
- Jul 2015
- First submitted
- 12 May 2015
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral and Subcutaneous Administration of GEN0101 in Patients With Recurrence of Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02502994
- Acronym / sponsor ID
- GEN0101-JM002
- Conditions
- Castration Resistant Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Norio NonomuraUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- 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 study is designed to evaluate the safety and efficacy of a single injection of GEN0101 in patients with recurrence of castration resistant prostate cancer.
The subjects receive GEN0101 injection 4 times per two weeks (1st intratumoral injection and followed subcutaneous injection) and two weeks of observation as one cycle treatment period. Each subject receive two cycle treatment period.
Low dose group: 30,000m NAU per injection of GEN0101 High dose group: 60,000m NAU per injection of GEN0101 Each group included minimal 3 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Drug: GEN0101Single arm of the castration resistant prostate cancer |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients providing a written informed consent by voluntary agreement.
- Age 20 =< and =<85 years old at the time of informed consent
- Have a diagnosis of malignant tumor as confirmed by histology or cytology.
- Have a diagnosis of recurrence of castration resistant prostate cancer and meet the following condition
- Serum PSA <100 ng/mL at the screening visit
Key exclusion criteria (12 listed)
- Have multiple brain metastases
- Positive result of the prick test of GEN0101
- Have serious complications such as uncontrolled active infection
- Received systemic chemotherapy, radiotherapy or immunotherapy within 6 weeks before the planned registration date However the hormone therapy except for the estramustine, enzalutamide and abiraterone, bisphosphonate and anti-RANKL antigen antibody is are not included in the systemic chemotherapy.
- Received another investigational medical product within 4 weeks before the informed concent
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 |
|---|---|---|
| GEN0101 | Drug | Intervention |
Primary outcome
DLT (Dose Limiting Toxicity)
Time frame: 8 weeks
To determine the appropriate dosing strategy for GEN0101 for castration resistant prostate cancer
4 secondary outcomes
Number of participants with tumor shrinkage according to the RECIST.
Time frame: 8 weeks
Change from baseline in tumor marker (PSA: Prostate Specific Antigen, NSE: Neuron-specific enolase, CEA: Carcinoembryonic Antigen, and CA19-9: Carbohydrate Antigen19-9) at Cycle 1, Week 4 and at Cycle 2, Week 4.
Time frame: 8 weeks
Change from baseline in prostate histological evaluation at Cycle2, Week2.
Time frame: 8 weeks
Change from baseline in induction of antitumor immunity (NK cell activity, IL-6 and IFN-gamma) at Cycle1, Week 2 and Week 4 and at Cycle2, Week 2 and Week 4.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
Related trials for Castration Resistant Prostate Cancer
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NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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.
Norio Nonomura, MD study chair
Urology, Osaka University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GEN0101 in people with Castration Resistant Prostate Cancer, run by Norio Nonomura at 1 site in Japan.
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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 20 Jul 2015. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norio Nonomura, MD (+81668793531, nono@uro.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (Dose Limiting Toxicity) (time frame: 8 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 20 Jul 2015.