Dose-Escalation Phase 1 Study of G-202 (Mipsagargin) in Patients With Advanced Solid Tumors

NCT01056029 | Completed Phase 1

• 1 other identifier: G-202-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open-label, single-arm, dose-escalation Phase I study to determine the maximum tolerated dose (MTD) of G-202 (mipsagargin) when administered once daily for 3 consecutive days of a 28-day cycle in patients with advanced solid tumors. G-202 will be administered by intravenous infusion over 1 hour on Days 1, 2 and 3 of each 28-day cycle.

Conditions

Advanced Solid Tumors

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Determine the MTD and DLT(s) of G-202 administered by intravenous infusion daily for 3 consecutive days on a 28-day cycle in patients with advanced solid tumors.

  2 years

• Establish the recommended dose of G-202 to be used in Phase II studies.

  2 years

• Determine the pharmacokinetics of G-202 administered by intravenous infusion daily for 3 consecutive days on a 28-day cycle in patients with advanced solid tumors.

  2 years

Secondary Outcomes (2)

• Investigate the safety profile of G-202 administered by intravenous infusion daily for 3 consecutive days on a 28-day cycle in patients with advanced solid tumors.

  2 years

• Document any evidence of anti-tumor activity, including response rate, disease stability, progression-free or overall survival, in response to G-202 administration

  2 years

Study Arms (1)

G-202

EXPERIMENTAL

Drug: G-202

Interventions

G-202 DRUG

Thapsigargin is Pro-drug chemotherapy which will be administered by intravenous infusion over 1 hour on Days, 1, 2 and 3 of each 28 day cycle

G-202

Eligibility Criteria

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

You may qualify if:

• Histologically-confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
• Disease that is measurable and/ or evaluable by RECIST criteria. Patients with prostate cancer require presence of disease on bone scan and/or CT scan and evidence of increasing PSA after standard hormonal therapy
• ECOG Performance Status ≤ 2
• Life expectancy estimated to be at least 3 months
• Acceptable liver function:
• In the absence of disease involvement in the liver and if bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be ≤ 2 times ULN
• In the presence of disease involvement in the liver and if bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be ≤ 5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN Patients with bone metastases alkaline phosphatases ≤ 5 times ULN
• Acceptable renal function:
• Serum creatinine ≤ 1.5 times ULN, OR
• Calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
• Acceptable hematologic status:
• Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
• Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
• Hemoglobin ≥ 9 g/dL

You may not qualify if:

• Documentation of keratosis follicularis, also known as Darier or Darier-White disease
• Known hypersensitivity to any study drug component, including thapsigargin derivatives, Polysorbate 20, or propylene glycol
• Patients with known and untreated brain metastases. Patients with brain metastases that have been treated and demonstrated to be clinically stable for at least 30 days may be enrolled onto the study
• Patients with a family history of coagulopathy or patients with DVT or pulmonary embolus within the last 6 months
• Patients taking anti-coagulants that include Coumadin or low molecular weight heparin
• Patients with pre-existing cardiac conditions:
• Prior documented myocardial infarction within the last 6 months
• Pre-existing cardiac failure (NYHA class III-IV)
• Atrial fibrillation on anti-coagulants
• Unstable angina
• Severe valvulopathy
• Cardiac angioplasty or stenting within the last 6 months
• Use or requirement for use of inhibitors or inducers of cytochrome isoenzymes
• Corrected QTc prolongation value, calculated using Bazett's formula (QTcB = QT/RR ½), \> 450 msec
• Pregnant or lactating females

Sponsors & Collaborators

• GenSpera, Inc.: lead

Study Sites (3)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

University of Texas, Health Science Center,Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

University of Wisconsin Paul P Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Study Officials

• George Wilding, M.D

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Michael Carducci, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Devalingam Mahalingam, MD

  University of Texas, Health Science Center,Cancer Therapy and Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: August 1, 2013
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

US (3)