GlioblastomaPhase 2NCT02876003
Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma
A Phase 2 study testing G-202 in people with Glioblastoma, run by GenSpera, Inc. at 1 site in United States.
Trial summary
Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50% of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- 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
- Sep 2016to Oct 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent to participate in this study
- Histological or radiological confirmation of glioblastoma with PSMA positivity
- Recurrent or progressive GBM following at least one (1), but no more than two (2) prior regimens; one of the prior regimens must have included surgery and/or radiotherapy
- Age >/= 18 years
- Karnofsky Performance Status (KPS) ≥ 60%
- Life expectancy > 2 months
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- Adequate hematologic, renal and hepatic function
- Adequate coagulation profile
- Not pregnant, nursing or planning to become pregnant; willing to use contraception
Who cannot join
- Deteriorating neurological symptoms, or need for increasing doses of corticosteroids or new onset of seizures
- Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week of first G-202 treatment
- Toxicity from prior therapy (excluding alopecia) that has not resolved to ≤ Grade 1 unless otherwise specified
- Investigational or cytotoxic therapy within 28 days or nitrosoureas within 42 days of the first treatment with G-202
- Currently requiring any type of full-dose anti-coagulation treatment, systemic administration of antibiotics or chronic administration of anti-viral agents.
- History or evidence of cardiac risk, including QTc interval on screening ECG >470 msec, left ventricular ejection fraction (LVEF) < 50%, clinically significant uncontrolled arrhythmias or arrhythmia requiring treatment with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia, history of acute coronary syndromes within 6 months prior to the first dose of study therapy (including myocardial infarction and unstable angina, coronary artery bypass graft, angioplasty, or stenting)
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- Uncontrolled cardiac or coronary artery disease
- Uncontrolled hypertension (mean systolic BP ≥ 160 mm Hg and/or mean diastolic BP ≥ 100 mm Hg on 3 determinations 5 minutes apart while on 2 anti-hypertensive agents) or hypertension requiring treatment with more than 2 anti-hypertensive agents
- Severe or uncontrolled medical disease, including uncontrolled diabetes, congestive heart failure, chronic renal disease or chronic pulmonary disease
- Severe GI bleeding within 12 weeks of treatment with G-202
- Known history of HIV, hepatitis B or hepatitis C
- Documentation of keratosis follicularis (also known as Darier or Darier-White disease)
- Requirement for chronic use of strong inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes
- Known hypersensitivity to any study drug component including thapsigargin derivatives, polysorbate 20, or propylene glycol
- Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements
- Another primary malignancy that has not been in remission for at least 2 years; non-melanoma skin cancer, intraepithelial carcinoma of the cervix, or prostate cancer with a current PSA ≤ 0.1 ng/mL is allowed-
Trial locations and contacts
1 site in 1 country.
United States1 site
John Wayne Cancer Institute
Santa Monica, California, 90404
About this study
Official title: An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy, Safety and CNS Exposure of G-202 in Patients With PSMA Positive Recurrent or Progressive Glioblastoma
Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50% of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to improve second-line therapy in GBM have met with only marginal success and there is a large unmet medical need for new therapies. G-202 (mipsagargin) is an example of prodrug chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM, 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. This study will evaluate the activity, safety and CNS exposure of G-202 in patients with PSMA-positive recurrent or progressive GMB receiving G-202 by intravenous infusion on three consecutive days of a 28-day cycle.
- Conditions
- Glioblastoma
- Being tested
- G-202
- Medical subject headings
- Glioblastoma
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 (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| G-202 (Mipsagargin) | Experimental | G-202 (Mipsagargin) 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.
6-month progression-free survival
Percentage of patients who received at least 2 cycles of G-202 and have not progressed, according to criteria of the Response Assessment in Neuro-Oncology Working Group (RANO), or died within 6 months of beginning treatment with G-202
Measured: 6 months
Secondary outcomes (4)
Safety
Proportion of patients experiencing treatment-emergent adverse events
Measured: Every 2 weeks for approximately 1 year
Objective tumor response rate, best overall response
Response rate assessed by RANO criteria
Measured: Every 8 weeks for approximately one year
Duration of PFS
Duration of time from the first administration of G-202 until the first documented progression or date of death, assessed up to 12 months
Measured: Every 4 weeks for approximately one year
Overall survival
Duration of time from the first administration of G-202 until the date of death, assessed up to 12 months
Measured: Every 4 weeks for approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: This study has been withdrawn prior to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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)
- Collaborators
- Saint John's Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Garni Barkhoudarian, M.D., Principal investigator, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876003
- Sponsor's protocol ID
- G-202-008
- Status last verified
- Feb 2017
- First submitted
- 18 Aug 2016
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
- An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy, Safety and CNS Exposure of G-202 in Patients With PSMA Positive Recurrent or Progressive Glioblastoma
- ClinicalTrials.gov ID
- NCT02876003
- Acronym / sponsor ID
- G-202-008
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been withdrawn prior to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GenSpera, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Saint John's Cancer Institute
- Study start
- Sep 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 23 Aug 2016 (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.
Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50% of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to improve second-line therapy in GBM have met with only marginal success and there is a large unmet medical need for new therapies. G-202 (mipsagargin) is an example of prodrug chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM, 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. This study will evaluate the activity, safety and CNS exposure of G-202 in patients with PSMA-positive recurrent or progressive GMB receiving G-202 by intravenous infusion on three consecutive days of a 28-day cycle.
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 (Mipsagargin) | Experimental | Drug: G-202G-202 (Mipsagargin) administered by intravenous infusion on 3 consecutive days of a 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent to participate in this study
- Histological or radiological confirmation of glioblastoma with PSMA positivity
- Recurrent or progressive GBM following at least one (1), but no more than two (2) prior regimens; one of the prior regimens must have included surgery and/or radiotherapy
- Age >/= 18 years
- Karnofsky Performance Status (KPS) ≥ 60%
Key exclusion criteria (16 listed)
- Deteriorating neurological symptoms, or need for increasing doses of corticosteroids or new onset of seizures
- Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week of first G-202 treatment
- Toxicity from prior therapy (excluding alopecia) that has not resolved to ≤ Grade 1 unless otherwise specified
- Investigational or cytotoxic therapy within 28 days or nitrosoureas within 42 days of the first treatment with G-202
- Currently requiring any type of full-dose anti-coagulation treatment, 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 (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity | Drug | G-202 (Mipsagargin) |
Primary outcome
6-month progression-free survival
Time frame: 6 months
Percentage of patients who received at least 2 cycles of G-202 and have not progressed, according to criteria of the Response Assessment in Neuro-Oncology Working Group (RANO), or died within 6 months of beginning treatment with G-202
4 secondary outcomes
Safety
Time frame: Every 2 weeks for approximately 1 year
Objective tumor response rate, best overall response
Time frame: Every 8 weeks for approximately one year
Duration of PFS
Time frame: Every 4 weeks for approximately one year
Overall survival
Time frame: Every 4 weeks for approximately one year
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 24 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Garni Barkhoudarian, M.D. principal investigator
Saint John's Cancer Institute
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 Glioblastoma, 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 9 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 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 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?
6-month progression-free survival (time frame: 6 months). 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.