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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Midazolam Pharmacokinetics, area under the concentration-time curve (AUC 0-tlast)

Outcome Time Frame:

4 days

Safety Issue:

No

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

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

13074

NCT ID:

NCT01209832

Start Date:

September 2010

Completion Date:

January 2011

Related Keywords:

  • Advanced Cancer
  • Metastatic Tumors
  • Lymphoma
  • Neoplasm Metastasis
  • Neoplasms

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