A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/8/2019 |
Start Date: | December 8, 2015 |
End Date: | April 28, 2017 |
A Phase I, Multicenter, Open-label, Single-sequence Drug-drug Interaction Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and
rosuvastatin in patients with cMET-dysregulated advanced solid tumors
rosuvastatin in patients with cMET-dysregulated advanced solid tumors
Inclusion Criteria:
Patients must have:
- advanced solid tumors and have confirmed cMET dysregulation
- at least one measurable lesion as defined by RECIST 1.1.
- recovered from all toxicities related to prior anti-cancer therapies
- adequate organ function
- ECOG performance status (PS) of 0 or 1
Exclusion Criteria:
Patients must not have:
- known hypersensitivity to any of the excipients of INC280
- prior treatment with cMET or HGF-targeting inhibitor
- known hypersensitivity to digoxin or rosuvastatin or its excipients
- symptomatic central nervous system (CNS) metastases who are neurologically unstable
- presence or history of carcinomatous meningitis
- history of another primary malignancy that is currently clinically significant or
currently requires active intervention
- Clinically significant, uncontrolled heart diseases, including QTcF ≥ 450 msec (male
patients), ≥ 460 msec (female patients) on the screening ECG
- Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280
- Major surgery within 4 weeks prior to starting INC280
- Patients receiving unstable or increasing doses of corticosteroids.
- Impairment of GI function or GI disease that may significantly alter the absorption of
INC280
- Patients who have received, or are expected to receive digoxin or rosuvastatin within
21 days prior to the beginning of the DDI phase (Day 1) and for the duration of the
DDI phase.
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
3
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Principal Investigator: Lionel Lewis
Phone: 603-650-6380
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Atlanta, Georgia 30322
Principal Investigator: Taofeek K. Owonikoko
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