Efficacy, Safety and CNS Exposure of G-202 (Mipsagargin) in Patients With Recurrent or Progressive Glioblastoma

NCT02067156 | Completed Phase 2 Results

• 2 other identifiers: G-202-004R01FD005077
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate if a drug called G-202 can be safely used to treat people with glioblastoma (GBM) that has progressed or recurred. G-202 is given by intravenous infusion on three consecutive days of a 28-day cycle.

Conditions

Glioblastoma Multiforme

Keywords

glioblastoma

Outcome Measures

Primary Outcomes (1)

• 6-month Progression-free Survival (PFS)

  Percentage of patients who received at least 2 cycles of G-202 and have not progressed or died within 6 months of beginning treatment with G-202. Progression is defined using Response Assessment in Neuro-Oncology Working Group (RANO) for high-grade glioma, as any of the following: by any of the following: 25% or greater increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor, or to decrease in corticosteroid dose.

  6 months

Secondary Outcomes (5)

• Toxicity Assessed by CTCAE v 4.03 Criteria

  Every 2 weeks for approximately one year

• Objective Tumor Response Rate

  approximately one year

• Duration of PFS

  Every 4 weeks for approximately one year

• Overall Survival

  Every 4 weeks for approximately one year

• Biomarkers in Tumor

  Within 4 weeks of receiving G-202

Study Arms (1)

G-202 (Mipsagargin)

EXPERIMENTAL

G-202 (Mipsagargin) administered by intravenous infusion on 3 consecutive days of a 28-day cycle

Drug: G-202

Interventions

G-202 DRUG

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

Also known as: Mipsagargin

G-202 (Mipsagargin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent to participate in this study
• Histological or radiological confirmation of glioblastoma
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GenSpera, Inc.: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

University of California, San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Dr. David Piccioni
• Organization: University of California, San Diego Moores Cancer Center

dpiccioni@ucsd.edu

858-657-7000

Study Officials

• David Piccioni, M.D., Ph.D.

  University of California, San Diego Moores Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2014
• First Posted: February 20, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Locations

US (1)