Study of AQ4N in Patients With Non Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia
A Phase 1/2, Open Label, Dose Escalation Study of AQ4N for Safety, Tolerability, Pharmacokinetics and Activity in Patients With Lymphoid Neoplasms
1 other identifier
interventional
55
1 country
1
Brief Summary
The purpose of this study is to find answers to the following questions:
- What is the largest dose of AQ4N that can be given safely one time every three weeks for 24 weeks?
- What are the side effects of AQ4N when given according to this schedule?
- How much AQ4N is in the blood at certain times after administration and how does the body get rid of the drug?
- Will AQ4N help treat lymphoid cancer?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2005
Typical duration for phase_1
1 active site
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, 2005
CompletedFirst Submitted
Initial submission to the registry
April 27, 2005
CompletedFirst Posted
Study publicly available on registry
April 27, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMay 7, 2007
May 1, 2007
April 27, 2005
May 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate
Secondary Outcomes (3)
Response duration and time to tumor progression
Time to treatment failure
Survival
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia
- Tumor specimen available for evaluation (please provide 10 unstained slides)
- Relapse after receiving primary treatment and at least one salvage therapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Laboratory test measurements
- Females of childbearing potential must have a negative pregnancy test result within 3 days prior to the first dose and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug.
- Older than 18 years of age
- Available for periodic blood sampling
You may not qualify if:
- Certain cardiac problems
- Previous donor stem cell transplant
- Known HIV, Hepatitis B, Hepatitis C infection
- Previous chemotherapy, radiation or other investigational drug treatments within 4 weeks of first planned dose of study drug
- Major surgery within four weeks of first planned dose of study drug
- Any active viral, bacterial, or fungal infection within four weeks of first planned dose of study drug
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novacealead
Study Sites (1)
Weill Medical College of Cornell University/ New York Presbyterian Hospital
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 27, 2005
First Posted
April 27, 2005
Study Start
March 1, 2005
Study Completion
March 1, 2007
Last Updated
May 7, 2007
Record last verified: 2007-05