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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

Phase 1
18 Years
Not Enrolling
Lymphoma, Advanced Cancer

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Trial Information

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics of tolbutamide, concurrent dosing, area under the curve (AUC 0-infinity)

Outcome Time Frame:

Period 2

Safety Issue:


Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

July 2010

Completion Date:

December 2010

Related Keywords:

  • Lymphoma
  • Advanced Cancer
  • Advanced or Metastatic Solid Tumors or Lymphoma
  • Lymphoma
  • Neoplasms