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A Tasisulam and Midazolam Drug Interaction Study in Cancer Patients

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ClinicalTrials.gov Identifier: NCT01209832
Recruitment Status : Terminated (Terminated based on safety results from another trial)
First Posted : September 27, 2010
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Tasisulam Drug: Midazolam Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : September 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Drug Interaction arm Drug: Tasisulam
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.
Other Name: LY573636
Drug: Midazolam
1.2mg, administered orally once prior to the initiation of tasisulam therapy and once on day 8 after initiation of tasisulam therapy



Primary Outcome Measures :
  1. Midazolam Pharmacokinetics, area under the concentration-time curve (AUC 0-tlast) [ Time Frame: 4 days ]
  2. Midazolam Pharmacokinetics, concentration maximum (Cmax) [ Time Frame: 4 days ]
  3. Midazolam Pharmacokinetics, area under the concentration-time curve (AUC 0-infinity) [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Number of participants with tumor response [ Time Frame: Baseline to study completion ]
  2. Tasisulam pharmacokinetics, concentration maximum (Cmax) [ Time Frame: 15 days ]
  3. Tasisulam pharmacokinetics AUC above the albumin corrected threshold [ Time Frame: 15 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209832


Locations
France
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.
Bordeaux, France, 33076
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.
Lille, France, 59020
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.
Rennes, France, 35033
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01209832     History of Changes
Other Study ID Numbers: 13074
H8K-MC-JZAP ( Other Identifier: Eli Lilly and Company )
2010-020090-16 ( EudraCT Number )
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by Eli Lilly and Company:
Metastatic Tumors
Lymphoma

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action