A Drug Interaction Study of Tasisulam in Patients With Advanced Cancer or Lymphoma

This study has been terminated.
(Terminated based on safety results from another trial)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01185548
First received: August 18, 2010
Last updated: April 12, 2011
Last verified: April 2011

August 18, 2010
April 12, 2011
July 2010
December 2010   (final data collection date for primary outcome measure)
Pharmacokinetics of tolbutamide, concurrent dosing, area under the curve (AUC 0-infinity) [ Time Frame: Period 2 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01185548 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of tolbutamide, staggered dosing, area under the curve (AUC 0-infinity). [ Time Frame: Period 3 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of tolbutamide, maximum concentration (Cmax) [ Time Frame: Period 1, 2 and 3 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of tolbutamide, observed time at maximal concentration (tmax) [ Time Frame: Period 1, 2 and 3 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Drug Interaction Study of Tasisulam in Patients With Advanced Cancer or Lymphoma
The Effect of Tasisulam on the CYP2C9-Mediated Metabolism of Tolbutamide: A Pharmacokinetic Interaction Study in Cancer Patients With Advanced and/or Metastatic Solid Tumors or Lymphoma

The purpose of this study is to assess the effect of tasisulam as an inhibitor of CYP2C9, using tolbutamide as a probe substrate. This study is comprised of three treatment periods, and continued access in an extension period. Period 1 is 4 days in length. Periods 2 and 3 are approximately 28 days in length.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Advanced Cancer
  • Drug: Tolbutamide
    Administered orally
  • Drug: Tasisulam
    Administered intravenously
    Other Name: LY573636
Experimental: Tasisulam and Tolbutamide

Three periods and continued access to study drug (tasisulam) every 28 days until disease progression:

Period 1: 500 mg tolbutamide administered once on Day 1

Period 2: 500 mg of tolbutamide and patient specific dose of tasisulam administered once on Day 1

Period 3: patient specific dose of tasisulam administered once on Day 1 and 500 mg tolbutamide administered once on day 4 (administration day in period 3 may be adjusted based on interim PK analyses)

Interventions:
  • Drug: Tolbutamide
  • Drug: Tasisulam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. Have given written informed consent prior to any study-specific procedures.
  3. 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.
  4. 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).
  5. Have adequate organ function.
  6. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
  7. 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.
  8. 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 Criteria:

  1. 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.
  2. Have known allergies to tasisulam or related compounds.
  3. Have serious preexisting medical conditions.
  4. 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.
  5. Have current acute or chronic leukemia.
  6. Females who are pregnant or lactating.
  7. Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
  8. History of severe allergies or multiple adverse drug reactions.
  9. Are persons who have previously completed or withdrawn from this study or any other study investigating tasisulam.
  10. 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.
  11. Serious concomitant systemic disorder, including diabetes or active infection, incompatible with the study.
  12. Clinically significant cardiac symptomology.
  13. Patients being treated with warfarin.
  14. Patients being treated with sulfonylureas
  15. Regularly use drugs of abuse and/or show positive findings on urinary drug screening that is not in accordance with known/acceptable concomitant medication.
  16. Patients who have received medications that are known inducers or inhibitors of CYP2C9 within 30 days prior to enrollment.
  17. Have donated or lost blood of more than 500 mL within the last month.
  18. 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 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
  19. Failure for any reason to satisfy the investigator for adequate fitness to participate in the study.
  20. Screening albumin levels less than 30 g/L.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01185548
13076, H8K-MC-JZAR
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP