A Tasisulam and Midazolam Drug Interaction Study in Cancer Patients

Lilly

Status and phase

Terminated

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: Midazolam

Drug: Tasisulam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01209832

H8K-MC-JZAP (Other Identifier)

2010-020090-16 (EudraCT Number)

13074

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
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 an estimated life expectancy, in the judgment of the investigator, of greater than or equal to 12 weeks

Exclusion criteria

Have received treatment within 30 days of the initial dose of study drug with an experimental agent for non-cancer indications that has not received regulatory approval for any indication
Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Patients with active brain metastasis are excluded
Have current acute or chronic leukemia
Patients who have clinically significant chronic obstructive pulmonary disease (COPD) or other respiratory diseases that may be at risk during periods of conscious sedation under midazolam
Patients with a known history of obstructive sleep apnea, difficult intubation, or syndromes associated with airway abnormalities.