Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876003
Recruitment Status : Withdrawn (This study has been withdrawn prior to enrollment.)
First Posted : August 23, 2016
Last Update Posted : February 24, 2017
Sponsor:
Collaborator:
John Wayne Cancer Institute
Information provided by (Responsible Party):
GenSpera, Inc.

Tracking Information
First Submitted Date  ICMJE August 18, 2016
First Posted Date  ICMJE August 23, 2016
Last Update Posted Date February 24, 2017
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • Safety [ Time Frame: Every 2 weeks for approximately 1 year ]
    Proportion of patients experiencing treatment-emergent adverse events
  • Objective tumor response rate, best overall response [ Time Frame: Every 8 weeks for approximately one year ]
    Response rate assessed by RANO criteria
  • Duration of PFS [ Time Frame: Every 4 weeks for approximately one year ]
    Duration of time from the first administration of G-202 until the first documented progression or date of death, assessed up to 12 months
  • Overall survival [ Time Frame: Every 4 weeks for approximately one year ]
    Duration of time from the first administration of G-202 until the date of death, assessed up to 12 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma
Official Title  ICMJE 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
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Drug: G-202
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
Other Name: Mipsagargin
Study Arms  ICMJE Experimental: G-202 (Mipsagargin)
G-202 (Mipsagargin) administered by intravenous infusion on 3 consecutive days of a 28-day cycle
Intervention: Drug: G-202
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 22, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
34
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • Adequate hematologic, renal and hepatic function
  • Adequate coagulation profile
  • Not pregnant, nursing or planning to become pregnant; willing to use contraception

Exclusion Criteria:

  • 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)
  • 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-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02876003
Other Study ID Numbers  ICMJE G-202-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GenSpera, Inc.
Study Sponsor  ICMJE GenSpera, Inc.
Collaborators  ICMJE John Wayne Cancer Institute
Investigators  ICMJE
Principal Investigator: Garni Barkhoudarian, M.D. John Wayne Cancer Institute
PRS Account GenSpera, Inc.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP