A Tasisulam and Midazolam Drug Interaction Study in Cancer Patients
This study has been terminated.
(Terminated based on safety results from another trial)
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01209832
First received: September 23, 2010
Last updated: April 12, 2011
Last verified: April 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: Tasisulam Drug: Midazolam |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Midazolam Pharmacokinetics, area under the concentration-time curve (AUC 0-tlast) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
- Midazolam Pharmacokinetics, concentration maximum (Cmax) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
- Midazolam Pharmacokinetics, area under the concentration-time curve (AUC 0-infinity) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants with tumor response [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
- Tasisulam pharmacokinetics, concentration maximum (Cmax) [ Time Frame: 15 days ] [ Designated as safety issue: No ]
- Tasisulam pharmacokinetics AUC above the albumin corrected threshold [ Time Frame: 15 days ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | September 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT01209832 History of Changes |
| Other Study ID Numbers: | 13074, H8K-MC-JZAP, 2010-020090-16 |
| Study First Received: | September 23, 2010 |
| Last Updated: | April 12, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
Metastatic Tumors Lymphoma |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Midazolam Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013