Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies
A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies
1 other identifier
interventional
85
1 country
2
Brief Summary
The purpose of this study is to determine the safety and the maximum tolerated dose of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2006
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 4, 2006
CompletedFirst Posted
Study publicly available on registry
April 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedDecember 24, 2015
December 1, 2015
7 years
April 4, 2006
December 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety, DLT, and MTD
Measured during the first cycle of treatment
Secondary Outcomes (1)
PK profile and disease response
Within the first 2 cycles of treatment
Study Arms (1)
Dose escalation
EXPERIMENTALTreatment Schedule 3 will consist of dosing on Days 1, 4, 8, and 11 of each 21 day cycle (3 weeks equals 1 cycle) and Treatment Schedule 4 will consist of dosing on Day 1 of each 28 day cycle (4 weeks equals 1 cycle)
Interventions
Dose increase by 25% if tolerated infused over 2 hours
Eligibility Criteria
You may qualify if:
- years of age or older
- Male or female
- Measurable or evaluable solid tumor malignancy
- Relapsed, refractory, locally advanced, or metastatic disease
- Disease refractory to or not amenable to standard therapy
- Karnofsky performance status 70-100%
- Life expectancy 3 months or greater
You may not qualify if:
- Pregnant or lactating women
- Primary central nervous system(CNS) malignancy or active CNS metastases
- Hematologic malignancy
- Chemotherapy within 4 weeks prior to study
- Mitomycin C, nitrosoureas within 6 weeks prior to study
- High dose chemotherapy with stem cell support within 6 months prior to study
- Signal transduction inhibitors, monoclonal antibodies, etc. within 4 weeks prior to study
- Systemic hormonal therapy within 4 weeks prior to study
- Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study
- Radiotherapy within 4 weeks prior to study
- Significant cardiovascular disease
- Serious/active infection
- Major surgical procedures within 2 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Wayne State University, Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
April 4, 2006
First Posted
April 5, 2006
Study Start
March 1, 2006
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
December 24, 2015
Record last verified: 2015-12