Prostatic NeoplasmsPhase 2NCT02381236
G-202 in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Prostate Cancer
A Phase 2 study testing G-202 in people with Prostatic Neoplasms, run by GenSpera, Inc. at 1 site in United States.
Trial summary
A single-arm, open-label Phase II clinical trial to evaluate the effect of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- G-202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2017
- Phase
- Phase 2
- 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
- ECOG Performance Status < 2
- Histological confirmation of prostatic adenocarcinoma that is confined to the prostate without evidence of regional and/or distant metastasis
- Clinical stage T1c or T2a with high-grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3
- Negative bone scan and CT of chest and abdomen within 6 weeks of first infusion of G-202
- Candidate for radical prostatectomy
- Adequate hematologic function (ANC ≥ 1200/mm3, hemoglobin ≥ 8.5 g/dL, platelets ≥ 75,000/mm3)
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- Adequate hepatic function (albumin ≥ 2.8 g/dL, AST and ALT ≤ 5 x ULN, total bilirubin < 2 mg/dL)
- Adequate renal function (proteinuria level ≤ 2+, serum creatinine ≤ 1.5 x ULN)
- Acceptable coagulation profile (no history of substantial non-iatrogenic bleeding diatheses, INR ≤ 2.3, aPTT ≤ 1.5 x ULN)
- Ejection fraction (LVEF) ≥ 45% measured by echocardiogram
- Willing to use acceptable methods of contraception to avoid pregnancy
Who cannot join
- Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features
- Unable to tolerate mpMRI
- Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week prior to first G-202 treatment
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or other investigational status drug for prostatic adenocarcinoma
- Currently requiring systemic administration of antibiotics or chronic administration of anti-viral agents
- Use of anti-coagulants is limited to local use for control of central line patency
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- History or evidence of cardiac risk
- Uncontrolled cardiac or coronary artery disease
- Uncontrolled hypertension or hypertension requiring treatment with more than 2 anti-hypertensive agents
- Severe or uncontrolled medical disease
- Severe gastrointestinal bleeding within 12 weeks prior to treatment with G-202
- Known history of HIV, hepatitis B or hepatitis C
- Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids
- Documentation of keratosis follicularis
- Requirement for chronic use of medications known to be strong inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes
- Another primary malignancy, except non-melanoma skin cancer, that has not been in remission for at least 2 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Sciences Center
Houston, Texas, 77030
About this study
Official title: G-202-005: An Open-Label, Single-Arm, Phase II Study to Evaluate the Safety and Activity of G-202 Administered in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Adenocarcinoma of the Prostate
A single-arm, open-label Phase II clinical trial to evaluate the effect of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI).
Read the detailed description
More than one-third of patients with localized high-risk prostate cancer who undergo radical prostatectomy eventually relapse with distant disease and some data suggest that neoadjuvant treatment in this patient population may be helpful. This study is based on prodrug tumor targeting, in which an inactive form of a toxic agent is administered systemically and gets activated in specific locations in the body, resulting in higher concentrations of the cytotoxic form at the tumor location. G-202 is a prodrug that is activated in prostate cancer tissue and in the blood vessels of tumors, but not normal tissue; once activated, G-202 leads to disruption of intracellular calcium levels and subsequent induction of apoptosis. Thus, G-202 is expected to bring about cell death in prostate cancer cells and to destroy the blood supply of prostate tumors. G-202 has led to disease stabilization in some patients, but the drug has not been evaluated in the neoadjuvant setting. This single-arm, open-label Phase II clinical trial will evaluate the safety and activity of G-202 in patients with localized high-risk prostate cancer prior to radical prostatectomy. Through its effects on the neovasculature of tumors, G-202 is anticipated to disrupt the blood supply of the prostate tumor, resulting in decreased perfusion and subsequent tumor volume. The primary endpoint of this study is evaluation of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI).
- Conditions
- Prostatic Neoplasms
- Being tested
- G-202
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-202Drug
Also called Mipsagargin
G-202 administered by intravenous infusion on Days 1, 2 and 3 of each 28-day cycle for up to 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| G-202 | Experimental | G-202 administered by intravenous infusion on 3 consecutive days of a 28-day cycle Receives: Drug: G-202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of the prostate using multiparametric prostate magnetic resonance imaging (mpMRI)
mpMRI performed after 3 cycles of treatment prior to prostatectomy
Measured: 12 weeks from first administration of G-202
Perfusion of the prostate using multiparametric prostate magnetic resonance imaging (mpMRI)
mpMRI performed after 3 cycles of treatment prior to prostatectomy
Measured: 12 weeks from first administration of G-202
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenSpera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Amato, D.O., Principal investigator, University of Texas Health Sciences Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381236
- Sponsor's protocol ID
- G-202-005
- Status last verified
- Feb 2017
- First submitted
- 23 Feb 2015
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-202-005: An Open-Label, Single-Arm, Phase II Study to Evaluate the Safety and Activity of G-202 Administered in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT02381236
- Acronym / sponsor ID
- G-202-005
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GenSpera, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Mar 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.
A single-arm, open-label Phase II clinical trial to evaluate the effect of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI).
Detailed description
More than one-third of patients with localized high-risk prostate cancer who undergo radical prostatectomy eventually relapse with distant disease and some data suggest that neoadjuvant treatment in this patient population may be helpful. This study is based on prodrug tumor targeting, in which an inactive form of a toxic agent is administered systemically and gets activated in specific locations in the body, resulting in higher concentrations of the cytotoxic form at the tumor location. G-202 is a prodrug that is activated in prostate cancer tissue and in the blood vessels of tumors, but not normal tissue; once activated, G-202 leads to disruption of intracellular calcium levels and subsequent induction of apoptosis. Thus, G-202 is expected to bring about cell death in prostate cancer cells and to destroy the blood supply of prostate tumors. G-202 has led to disease stabilization in some patients, but the drug has not been evaluated in the neoadjuvant setting. This single-arm, open-label Phase II clinical trial will evaluate the safety and activity of G-202 in patients with localized high-risk prostate cancer prior to radical prostatectomy. Through its effects on the neovasculature of tumors, G-202 is anticipated to disrupt the blood supply of the prostate tumor, resulting in decreased perfusion and subsequent tumor volume. The primary endpoint of this study is evaluation of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G-202 | Experimental | Drug: G-202G-202 administered by intravenous infusion on 3 consecutive days of a 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ECOG Performance Status < 2
- Histological confirmation of prostatic adenocarcinoma that is confined to the prostate without evidence of regional and/or distant metastasis
- Clinical stage T1c or T2a with high-grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3
- Negative bone scan and CT of chest and abdomen within 6 weeks of first infusion of G-202
- Candidate for radical prostatectomy
Key exclusion criteria (16 listed)
- Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features
- Unable to tolerate mpMRI
- Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week prior to first G-202 treatment
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or other investigational status drug for prostatic adenocarcinoma
- Currently requiring systemic administration of antibiotics or chronic administration of anti-viral agents
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 |
|---|---|---|
| G-202Also: MipsagarginG-202 administered by intravenous infusion on Days 1, 2 and 3 of each 28-day cycle for up to 3 cycles | Drug | G-202 |
Primary outcome
Volume of the prostate using multiparametric prostate magnetic resonance imaging (mpMRI)
Time frame: 12 weeks from first administration of G-202
mpMRI performed after 3 cycles of treatment prior to prostatectomy
Perfusion of the prostate using multiparametric prostate magnetic resonance imaging (mpMRI)
Time frame: 12 weeks from first administration of G-202
mpMRI performed after 3 cycles of treatment prior to prostatectomy
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 24 Feb 2017.
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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.
Robert Amato, D.O. principal investigator
University of Texas Health Sciences Center at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G-202 in people with Prostatic Neoplasms, run by GenSpera, Inc. at 1 site in United States.
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 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: finished, as of the sponsor's last update on 24 Feb 2017. 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 United States. 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 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?
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?
Volume of the prostate using multiparametric prostate magnetic resonance imaging (mpMRI) (time frame: 12 weeks from first administration of G-202). The study lists 2 primary outcomes in all. 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 24 Feb 2017.