Status:
TERMINATED
A Drug Interaction Study of Tasisulam in Patients With Advanced Cancer or Lymphoma
Lead Sponsor:
Eli Lilly and Company
Conditions:
Lymphoma
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study was to assess the effect of tasisulam as an inhibitor of CYP2C9, using tolbutamide as a probe substrate. This study was to have 3 treatment periods, and continued access in a...
Eligibility Criteria
Inclusion
- Have histologically or cytologically confirmed solid malignancy or lymphoma that is advanced and/or metastatic disease which has not responded to standard therapy or for which no standard therapy exists.
- Have given written informed consent prior to any study-specific procedures.
- Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale and an estimated life expectancy of greater than 12 weeks.
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days (45 days for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy. Limited field radiotherapy is permitted (in consultation with the investigator).
- Have adequate organ function.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug.
- Females with child-bearing potential must have had a negative serum pregnancy test less than 7 days prior to the first dose of study drug.
Exclusion
- Have received treatment within 30 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
- Have known allergies to tasisulam or related compounds.
- Have serious preexisting medical conditions.
- Show evidence of significant active neuropsychiatric disease or central nervous system (CNS) disease (for example, Alzheimer's disease or Parkinson's disease). Patients with active brain metastasis are excluded.
- Have current acute or chronic leukemia.
- Females who are pregnant or lactating.
- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
- History of severe allergies or multiple adverse drug reactions.
- Are persons who have previously completed or withdrawn from this study or any other study investigating tasisulam.
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
- Serious concomitant systemic disorder, including diabetes or active infection, incompatible with the study.
- Clinically significant cardiac symptomology.
- Patients being treated with warfarin.
- Patients being treated with sulfonylureas
- Regularly use drugs of abuse and/or show positive findings on urinary drug screening that is not in accordance with known/acceptable concomitant medication.
- Patients who have received medications that are known inducers or inhibitors of CYP2C9 within 30 days prior to enrollment.
- Have donated or lost blood of more than 500 milliliter (mL) within the last month.
- Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females) (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
- Failure for any reason to satisfy the investigator for adequate fitness to participate in the study.
- Screening albumin levels less than 30 grams/Liter (g/L).
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01185548
Start Date
July 1 2010
End Date
December 1 2010
Last Update
October 19 2018
Active Locations (5)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cardiff, South Glamorgan, United Kingdom, CF14 2TL
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sheffield, Trent, United Kingdom, S10 2SJ
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Leeds, West Yorkshire, United Kingdom, LS9 7TF
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Leicester, United Kingdom, LE1 5WW