Prostate Cancer.Phase 2NCT01734681
Phase 2 Study of G-202 in Patients With Chemotherapy-Naïve Metastatic Castrate-Resistant Prostate Cancer
A Phase 2 study testing G-202 in people with Prostate Cancer., run by GenSpera, Inc. at 1 site in United States.
Trial summary
Prostate cancer that has returned after local treatment usually responds to hormone blocking treatment, but most patients eventually experience disease progression. Further chemotherapy does not normally lead to a cure or dramatic improvement in the disease and there is a need to identify new drugs that are beneficial… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer.
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jan 2015
- 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
- Confirmed prostate adenocarcinoma
- Asymptomatic or minimally symptomatic
- Radiographic metastatic or recurrent disease
- Chemically- or surgically-castrated with disease progression
- Castrate testosterone level <50 ng/dL
- Discontinued flutamide, bicalutamide and nilutamide
Show all 20Show fewer
- Absence of known brain metastases
- Age ≥18 years
- Eastern Cooperative Oncology Group performance status ≤ 2
- Estimated life expectancy ≥ 6 months
- Adequate hematopoietic function as demonstrated by:
- hemoglobin of ≥ 9.0 g/dL without need for sustained blood transfusions
- platelet count ≥100,000 platelet/mm3 (100 x 109/L)
- White Blood Cell (WBC) count ≥ 2.0 x109/L and Absolute Neutrophil Count (ANC) ≥1.5 x109/L
- Adequate hepatobiliary function as demonstrated by:
- Total bilirubin level ≤1.5 times the upper limit of normal (ULN), unless the patient has Gilbert's syndrome in which case the patient must have a total bilirubin level ≤ 2.5 x ULN
- alanine aminotransferase (ALT) levels ≤ 2.5 x ULN
- Adequate renal function as demonstrated by creatinine level ≤1.5 x ULN or creatinine clearance (measured or calculated by Cockcroft-Gault formula) ≥ 50mL/min
- Acceptable coagulation profile (PT or INR, PTT < 1.5 x ULN)
- If of reproductive capacity, willing to use an effective double barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc) during the study and for 30 days after the last administration of G-202
Who cannot join
- Prior chemotherapy
- Other concurrent therapy for prostate cancer other than LHRH agonists or antagonists.
- Treatment with therapeutic radionucleotides within 12 weeks of study entry
- Radiation therapy < 4 weeks before study entry
- Documentation of keratosis follicularis
- Pre-existing cardiac condition:
Show all 11Show fewer
- use of inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes
- Chronic use of opioids for cancer-related pain
- Corrected QT interval > 470 msec
- Active uncontrolled infection, including known history of AIDS, hepatitis B or C
- Proteinuria level > +2 on urine analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center
San Antonio, Texas, 78229-3900
About this study
Official title: An Open-Label, Single-Arm, Phase 2 Study of G-202 in Patients With Chemotherapy-Naïve Metastatic Castrate-Resistant Prostate Cancer
Prostate cancer that has returned after local treatment usually responds to hormone blocking treatment, but most patients eventually experience disease progression. Further chemotherapy does not normally lead to a cure or dramatic improvement in the disease and there is a need to identify new drugs that are beneficial for these patients without unacceptable side effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is administered to the patient and gets activated within the body at specific locations, resulting in a higher concentration of the cytotoxic form at a tumour location whilst avoiding general side effects. G-202 is an example of prodrug chemotherapy. It does not have many general side effects because it is converted to a cell toxin only at the tumour or other specific locations in the body. G-202 is activated by Prostate Specific Memory Antigen (PSMA), a substance expressed by prostate cancer cells and in the blood vessels of most solid tumours, but not by normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug G-202 will allow the drug to kill cancer cells, particularly prostate cancer cells. This study will evaluate the activity and safety of G-202 in men with castration-resistant prostate cancer (CRPC), which means the cancer has progressed after hormone blocking treatment, but who have not yet received chemotherapy and who have no or only a few symptoms from their CRPC. The study will evaluate clinical activity and safety of G-202 administered on three consecutive days of a 28-day cycle.
Read the detailed description
Patients will undergo a screening period of up to 4 weeks. Patients who are deemed eligible will be entered into the study and undergo treatment with G-202. G-202 will be administered by intravenous infusion over one hour on Days 1, 2 and 3 of a 28-day treatment cycle. The G-202 dose will be 40 mg/m2 on Day 1 and 66.8 mg/m2 on Days 2 and 3.
The primary objective of the study is to determine the percentage of patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer who do not have disease progression (radiographic or clinical) after 24 weeks of treatment with G-202.
A two-stage study design will be used to evaluate the percentage of patients who do not have disease progression after 24 weeks of treatment with G-202. If the percent of patients who are progression-free at 24 weeks is at most 15%, then the clinical efficacy of G-202 in this patient population will be considered unacceptably low. If, on the other hand, the percent of patients who are progression-free at 24 weeks is at least 35%, this will be considered sufficient evidence to consider further clinical investigation. The null hypothesis that the percent of patients who are progression-free at 24 weeks is at most 15% will be tested against the alternative hypothesis that the percent is greater than 15% at the one-sided 10% significance level. In order to avoid a suspension in accrual awaiting interim analysis, a two-stage study design for evaluating survival probabilities with continual accrual will be used.
An interim analysis for futility will be conducted after 24 evaluable patients have been accrued assuming that the time between accrual of the first patient and accrual of the 24th patient is at least 8 months. If 24 patients are accrued in less than 8 months, accrual will continue until the time period between the date of accrual of the first patient and the date of accrual of the last patient is at least 8 months. If the trial is not terminated for futility after the interim analysis, an additional 10 patients will be accrued for a total of 34 patients. The two-stage design minimizes the expected duration of accrual under the null hypothesis.
For the interim analysis, any patient who discontinues participation for reasons other than safety or disease progression before completing three full cycles and undergoing the 12-week follow-up assessment will be replaced. Any replaced patient will be included in all study analyses of the intent-to-treat and safety populations.
Safety will be assessed by the reporting of adverse events, vital signs and assessment of findings on physical exam and routine laboratory determinations. The severity of adverse events and laboratory findings will be assessed according to NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.
- Conditions
- Prostate Cancer.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Treatment with G-202 | Experimental | G-202 will be administered by intravenous infusion over one hour on Days 1, 2 and 3 of a 28-day treatment cycle. The G-202 dose will be 40 mg/m2 on Day 1 and 66.8 mg/m2 on Days 2 and 3. Receives: Drug: G-202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who are progression-free after 24 weeks of treatment with G-202
Determine the percentage of patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer who do not have disease progression (radiographic or clinical) after 24 weeks of treatment with G-202
Measured: 24 weeks
Secondary outcomes (7)
Maximum prostatic specific antigen (PSA) change from baseline at any time
Measured: Every 4 weeks
Percent change in PSA from baseline to 24 weeks
Measured: 24 weeks
Time to PSA progression
Measured: Every 4 weeks
PSA Doubling time
Measured: Every 4 weeks
Best Objective Response
Measured: Every 12 weeks
Time to Disease Progression
Measured: Every 12 weeks
Progression Free Survival
Measured: Every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startMay 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer.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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenSpera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734681
- Sponsor's protocol ID
- G202-002
- Status last verified
- Feb 2013
- First submitted
- 19 Nov 2012
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase 2 Study of G-202 in Patients With Chemotherapy-Naïve Metastatic Castrate-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01734681
- Acronym / sponsor ID
- G202-002
- Conditions
- Prostate Cancer.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GenSpera, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 28 Nov 2012 (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.
Prostate cancer that has returned after local treatment usually responds to hormone blocking treatment, but most patients eventually experience disease progression. Further chemotherapy does not normally lead to a cure or dramatic improvement in the disease and there is a need to identify new drugs that are beneficial for these patients without unacceptable side effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is administered to the patient and gets activated within the body at specific locations, resulting in a higher concentration of the cytotoxic form at a tumour location whilst avoiding general side effects. G-202 is an example of prodrug chemotherapy. It does not have many general side effects because it is converted to a cell toxin only at the tumour or other specific locations in the body. G-202 is activated by Prostate Specific Memory Antigen (PSMA), a substance expressed by prostate cancer cells and in the blood vessels of most solid tumours, but not by normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug G-202 will allow the drug to kill cancer cells, particularly prostate cancer cells. This study will evaluate the activity and safety of G-202 in men with castration-resistant prostate cancer (CRPC), which means the cancer has progressed after hormone blocking treatment, but who have not yet received chemotherapy and who have no or only a few symptoms from their CRPC. The study will evaluate clinical activity and safety of G-202 administered on three consecutive days of a 28-day cycle.
Detailed description
Patients will undergo a screening period of up to 4 weeks. Patients who are deemed eligible will be entered into the study and undergo treatment with G-202. G-202 will be administered by intravenous infusion over one hour on Days 1, 2 and 3 of a 28-day treatment cycle. The G-202 dose will be 40 mg/m2 on Day 1 and 66.8 mg/m2 on Days 2 and 3.
The primary objective of the study is to determine the percentage of patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer who do not have disease progression (radiographic or clinical) after 24 weeks of treatment with G-202.
A two-stage study design will be used to evaluate the percentage of patients who do not have disease progression after 24 weeks of treatment with G-202. If the percent of patients who are progression-free at 24 weeks is at most 15%, then the clinical efficacy of G-202 in this patient population will be considered unacceptably low. If, on the other hand, the percent of patients who are progression-free at 24 weeks is at least 35%, this will be considered sufficient evidence to consider further clinical investigation. The null hypothesis that the percent of patients who are progression-free at 24 weeks is at most 15% will be tested against the alternative hypothesis that the percent is greater than 15% at the one-sided 10% significance level. In order to avoid a suspension in accrual awaiting interim analysis, a two-stage study design for evaluating survival probabilities with continual accrual will be used.
An interim analysis for futility will be conducted after 24 evaluable patients have been accrued assuming that the time between accrual of the first patient and accrual of the 24th patient is at least 8 months. If 24 patients are accrued in less than 8 months, accrual will continue until the time period between the date of accrual of the first patient and the date of accrual of the last patient is at least 8 months. If the trial is not terminated for futility after the interim analysis, an additional 10 patients will be accrued for a total of 34 patients. The two-stage design minimizes the expected duration of accrual under the null hypothesis.
For the interim analysis, any patient who discontinues participation for reasons other than safety or disease progression before completing three full cycles and undergoing the 12-week follow-up assessment will be replaced. Any replaced patient will be included in all study analyses of the intent-to-treat and safety populations.
Safety will be assessed by the reporting of adverse events, vital signs and assessment of findings on physical exam and routine laboratory determinations. The severity of adverse events and laboratory findings will be assessed according to NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with G-202 | Experimental | Drug: G-202G-202 will be administered by intravenous infusion over one hour on Days 1, 2 and 3 of a 28-day treatment cycle. The G-202 dose will be 40 mg/m2 on Day 1 and 66.8 mg/m2 on Days 2 and 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Confirmed prostate adenocarcinoma
- Asymptomatic or minimally symptomatic
- Radiographic metastatic or recurrent disease
- Chemically- or surgically-castrated with disease progression
- Castrate testosterone level <50 ng/dL
Key exclusion criteria (11 listed)
- Prior chemotherapy
- Other concurrent therapy for prostate cancer other than LHRH agonists or antagonists.
- Treatment with therapeutic radionucleotides within 12 weeks of study entry
- Radiation therapy < 4 weeks before study entry
- Documentation of keratosis follicularis
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-202 | Drug | Treatment with G-202 |
Primary outcome
Percentage of patients who are progression-free after 24 weeks of treatment with G-202
Time frame: 24 weeks
Determine the percentage of patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer who do not have disease progression (radiographic or clinical) after 24 weeks of treatment with G-202
7 secondary outcomes
Maximum prostatic specific antigen (PSA) change from baseline at any time
Time frame: Every 4 weeks
Percent change in PSA from baseline to 24 weeks
Time frame: 24 weeks
Time to PSA progression
Time frame: Every 4 weeks
PSA Doubling time
Time frame: Every 4 weeks
Best Objective Response
Time frame: Every 12 weeks
Time to Disease Progression
Time frame: Every 12 weeks
Progression Free Survival
Time frame: Every 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
Related trials for Prostate Cancer.
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
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 Prostate Cancer., 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 20 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: withdrawn, as of the sponsor's last update on 19 Feb 2014. 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 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?
Percentage of patients who are progression-free after 24 weeks of treatment with G-202 (time frame: 24 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 19 Feb 2014.