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A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of the CYP1A2 Inhibitor, Fluvoxamine, on Dovitinib (TKI258) Pharmacokinetics in Patients With Advanced Solid Tumors


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 the CYP1A2 Inhibitor, Fluvoxamine, on Dovitinib (TKI258) Pharmacokinetics in Patients With Advanced Solid Tumors


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 an
anticipated life expectancy of ≥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 or
CYP3A inhibitor medications within 5 days prior to start study treatment or are expected
to receive during the first 28 days after starting the study treatment - Patients who have
received CYP1A2 or CYP3A inducer medications within 30 days prior to start study treatment
or are expected to receive during the first 28 days after starting the study treatment -
Patients who are actively taking antidepressants, benzodiazepines, serotonergic drugs,
and/or monoamine oxidase inhibitors (MAOIs) - 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:

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

Outcome Measure:

TKI258 pharmacokinetics (PK) parameters: Cmax (Maximum (peak) concentration of drug)

Outcome Time Frame:

multiple time-points over 72h post dose on day Day 19 and Day 26 (PK 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:

CTKI258A2120

NCT ID:

NCT01700270

Start Date:

May 2013

Completion Date:

April 2014

Related Keywords:

  • Advanced Solid Tumors, Excluding Breast Cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location

Montefiore Medical Center Montefiore Medical Center (SC)Bronx, New York  10467
Cancer Therapy & Research Center / UT Health Science Center SCSan Antonio, Texas  78229
Washington University School Of Medicine-Siteman Cancer Ctr Wash UnivSt. Louis, Missouri  63110