Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors. (CTKI258A2120)

This study is currently recruiting participants.
Verified November 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01700270
First received: October 2, 2012
Last updated: November 6, 2013
Last verified: November 2013

October 2, 2012
November 6, 2013
May 2013
April 2014   (final data collection date for primary outcome measure)
  • TKI258 pharmacokinetics (PK) parameters: Cmax (Maximum (peak) concentration of drug) [ Time Frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase) ] [ Designated as safety issue: No ]
  • TKI258 pharmacokinetics (PK) parameters: AUC 0-24 hr (Area Under the Curve) [ Time Frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase) ] [ Designated as safety issue: No ]
  • TKI258 pharmacokinetics (PK) parameters: AUC 0-72 hr [ Time Frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase) ] [ Designated as safety issue: No ]
  • TKI258 pharmacokinetics (PK) parameters: Tmax (Time to maximum concentration) [ Time Frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase) ] [ Designated as safety issue: No ]
  • TKI258 pharmacokinetics (PK) parameters: T1/2 (Half-life time) [ Time Frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase) ] [ Designated as safety issue: No ]
  • TKI258 pharmacokinetics (PK) parameters: CL/F (Apparent Oral Clearance) [ Time Frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase) ] [ Designated as safety issue: No ]
  • TKI258 pharmacokinetics (PK) parameters: Vz/F (apparent volume of distribution) [ Time Frame: multiple time-points over 72h post dose on day Day 19 and Day 26 (PK phase) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01700270 on ClinicalTrials.gov Archive Site
  • Frequency and severity of AEs (Adverse Events) [ Time Frame: up to at least 30 days after the last dose of dovitinib (TKI258) ] [ Designated as safety issue: Yes ]
  • Frequency and severity of SAEs (Serious Adverse Events) [ Time Frame: up to at least 30 days after the last dose of dovitinib (TKI258) ] [ Designated as safety issue: Yes ]
  • Preliminary evidence of antitumor activity of dovitinib (TKI258) [ Time Frame: every 8 weeks until progression of disease ] [ Designated as safety issue: No ]
    overall response based on investigator assessment and best overall response using RECIST 1.1
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors.
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

This is a multi-center, open-label, single-sequence, crossover, drug-drug interaction (DDI) study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on the PK of dovitinib in patients with advanced solid tumors, excluding breast cancer. The purpose of this study is to evaluate the effect of a CYP1A2 inhibitor, 100 mg fluvoxamine, on the PK of dovitinib when administered at a dose of 300 mg on the dosing schedule, 5 days on/2 days off. The study will consist of 2 phases: a Pharmacokinetic (PK) phase and a clinical treatment phase. The DDI test will be conducted in the PK phase. The DDI test will assess the steady state PK profile of dovitinib when administered alone and in the presence of the CYP1A2 inhibitor, fluvoxamine (AUC 0-24h, AUC 0-72h and Cmax parameters). During the clinical treatment phase patients may continue to receive treatment with TKI258 until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors, Excluding Breast Cancer
  • Drug: dovitinib (TKI258)
  • Drug: fluvoxamine
    perpetrator drug; 7 days of dosing
Experimental: dovitinib (TKI258)
dovitinib, 5 days on / 2 days off dose schedule
Interventions:
  • Drug: dovitinib (TKI258)
  • Drug: fluvoxamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
April 2014
April 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Denmark,   Netherlands,   Switzerland
 
NCT01700270
CTKI258A2120, 2012-001546-18
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP