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A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of TKI258 on the Pharmacokinetics of Caffeine, Diclofenac, Omeprazole and Midazolam Administered as a Four-drug Cocktail in Patients With Advanced Solid Tumors, Excluding Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors, Excluding Breast Cancer

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Trial Information

A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of TKI258 on the Pharmacokinetics of Caffeine, Diclofenac, Omeprazole and Midazolam Administered as a Four-drug Cocktail in Patients With Advanced Solid Tumors, Excluding Breast Cancer


Inclusion Criteria:



- Patients with a cytopathologically or histopathologically confirmed diagnosis of an
advanced solid tumor, excluding breast cancer which has progressed despite standard
therapy or for which no standard therapy exists

- ECOG performance status 0 or 1 and anticipated life expectancy ≥ 3 months

- Patient must meet protocol-specific laboratory values

Exclusion Criteria:

- Patients with brain metastases

- Patients who have received or who are expected to receive any prohibited medications
and therapies

- Patients who have received CYP1A2 inducer, CYP2C9/2C19 inducer or CYP3A4 inducer
medications within 30 days prior to start study treatment or are expected to receive
during the first 14 days after starting the study treatment

- Patients with a known hypersensitivity to benzodiazepines

- Patients who have not recovered from previous anti-cancer therapies

- Patient with impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of TKI258

- Patients who have concurrent severe and/or uncontrolled concomitant medical
conditions that could compromise participation in the study

- Female patients who are pregnant or breast-feeding

- Fertile males or women not willing to use highly effective methods of contraception

- Other protocol-defined inclusion/exclusion criteria will apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Probe substrate pharmacokinetics (PK) parameters: Cmax (Maximum (peak) concentration of drug)

Outcome Time Frame:

multiple time-points over 24h post dose on day 1 and Day 13 (DDI phase),

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2119

NCT ID:

NCT01596647

Start Date:

May 2012

Completion Date:

July 2013

Related Keywords:

  • Advanced Solid Tumors, Excluding Breast Cancer
  • cancer, tumors, phase I, drug-drug interaction, pharmacokinetic, probe drug, caffeine, diclofenac, omeprazole, midazolam, CYP1A2, CYP2C9, CYP2C19, CYP3A4
  • Breast Neoplasms
  • Neoplasms

Name

Location

University of Minnesota Minneapolis, Minnesota  55455
Henry Ford Hospital Henry Ford Detroit, Michigan  48202
University of Kansas Cancer Center Medical Center Kansas City, Kansas  66160
Comprehensive Cancer Centers Las Vegas, Nevada  89169
Cancer Institute of New Jersey Dept of Cancer Institute of NJ New Brunswick, New Jersey  08901