Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Neoplasm Metastasis

Lymphoma

Lymphosarcoma

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Midazolam

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

Patient specific dose, administered intravenously, on Day 1 of a 28-day cycle. Minimum of one (1) 28-day cycle. Patients may continue to receive tasisulam until disease progression or until discontinuation criteria are met.

Tasisulam

1.2 milligrams (mg), administered orally once prior to the initiation of tasisulam therapy and once on Day 8 after initiation of tasisulam therapy

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)

The purpose of this study is to evaluate whether tasisulam acts as an inducer of CYP3A using midazolam as a sensitive and specific probe substrate of CYP3A.

The study will also assess the safety and tolerability of tasisulam and midazolam given in combination and document any antitumor activity with tasisulam.

A Tasisulam and Midazolam Drug Interaction Study in Cancer Patients

The Effect of Tasisulam on CYP3A-mediated Metabolism of Midazolam: A Pharmacokinetic Interaction Study in Cancer Patients With Advanced and/or Metastatic Tumors or Lymphoma

Number of participants with tumor response = number of participants with complete response (CR) + number of participants with partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.

Tasisulam is highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) tasisulam.

Eli Lilly and Company

Period 1 (7 days): 1.2 milligrams (mg) midazolam orally on Day 1.

Period 2 (28 days): Tasisulam intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms per milliliter (h\*mcg/mL) on Day 1 and 1.2 mg midazolam orally on Day 8.

Tasisulam and Midazolam

Maintenance Period 1 (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h\*mcg/mL on Day 1.

Tasisulam (M1)

Maintenance Period 2 (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h\*mcg/mL on Day 1.

Tasisulam (M2)

Period 1 (7 days): 1.2 milligrams (mg) midazolam orally on Day 1.

Period 2 (28 days): Tasisulam intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms per milliliter (h\*mcg/mL) on Day 1 and 1.2 mg midazolam orally on Day 8.

Maintenance Period (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h\*mcg/mL on Day 1.

Midazolam + Tasisulam

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

France

Region of Enrollment

All participants who received at least one dose of the study drug.

Chief Medical Officer

Period 2 (28 days): Tasisulam was dosed intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms per milliliter (h\*mcg/mL) on Day 1 and followed by 1.2 mg midazolam orally on Day 8.

All participants who received study drug and had sufficient pharmacokinetics data to calculate AUC0-tlast. Analysis used data according to the treatment the participants actually received.

Midazolam Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With Measurable Concentrations (AUC 0-tlast)

All participants who received study drug and had sufficient pharmacokinetics data to estimate Cmax. Analysis used data according to the treatment the participants actually received.

Midazolam Pharmacokinetics: Maximum Concentration (Cmax)

All participants who received study drug and had sufficient pharmacokinetics data to calculate AUC0-infinity. Analysis used data according to the treatment the participants actually received.

Midazolam Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0-infinity)

All participants who received study drug.

Number of Participants With Tumor Response

Period 2 (28 days): Tasisulam was dosed intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms per milliliter (h\*mcg/mL) on Day 1 and followed by 1.2 milligrams (mg) midazolam orally on Day 8.

All participants who received tasisulam and had pharmacokinetics data.

Tasisulam Pharmacokinetics: Maximum Concentration (Cmax)

Period 2 (28 days): Tasisulam was dosed intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms per milliliter (h\*mcg/mL) on Day 1 and followed by 1.2 milligrams (mg) midazolam orally on Day 8

Tasisulam Pharmacokinetics: Area Under the Concentration-Time Curve Above the Albumin Corrected Threshold (AUCalb)

Period 1 (7 days): 1.2 milligrams (mg) midazolam orally on Day 1.

Period 2 (28 days): Tasisulam intravenously to target area under the curve above the albumin corrected threshold (AUCalb) in the range of 1200 to 6400 hour\*micrograms per milliliter (h\*mcg/mL) on Day 1 and 1.2 mg midazolam orally on Day 8.

Maintenance Period 1 and 2 (35 days): Tasisulam was dosed intravenously to target AUCalb in the range of 1200 to 6400 h\*mcg/mL on Day 1.

Spots Global Cancer Trial Database for A Tasisulam and Midazolam Drug Interaction Study in Cancer Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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