A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.
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ClinicalTrials.gov Identifier: NCT02925104 |
Recruitment Status :
Completed
First Posted : October 5, 2016
Last Update Posted : December 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
cMET Dysegulation Advanced Solid Tumors | Drug: INC280 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Open Label, Phase 1 Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INC280 Tablet Formulation With Food in Patients With cMET Dysregulated Advanced Solid Tumors. |
Actual Study Start Date : | December 14, 2016 |
Actual Primary Completion Date : | May 16, 2018 |
Actual Study Completion Date : | May 16, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: INC280 |
Drug: INC280 |
- Incidence of Dose limiting toxiticites (DLTs) [ Time Frame: During the first 28 days on INC280 treatment; cycle = 21 days ]
- Frequency of DLTs [ Time Frame: During the first 28 days on INC280 treatment ]
- Category of DLTs [ Time Frame: During the first 28 days on INC280 treatment ]
- AUClast for INC280 [ Time Frame: Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1 ]
- AUCtau for INC280 [ Time Frame: C1D1, C1D7, C1D15, C2D1, C3D1 ]
- Cmax for INC280 [ Time Frame: C1D1, C1D7, C1D15, C2D1, C3D1 ]
- Tmax [ Time Frame: C1D1, C1D7, C1D15, C2D1, C3D1 ]
- Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results). [ Time Frame: Screening, until 30 days post-treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- cMET dysregulated advanced solid tumor
- At least one measurable lesion as defined by RECIST 1.1
- Recovered from all toxicities related to prior anti-cancer therapies to grade ≤ 1
- Adequate organ function
- ECOG performance status (PS) ≤ 1
Exclusion Criteria:
- Prior treatment with crizotinib or any other cMET or HGF inhibitor
- Known hypersensitivity to any of the excipients of INC280
- Symptomatic central nervous system (CNS) metastases who are neurologically unstable
- Presence or history of a malignant disease other than the study related cancer
- Clinically significant, uncontrolled heart diseases
- Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities
- Major surgery within 4 weeks prior to starting INC280
- Impairment of GI function
- Patients receiving unstable or increasing doses of corticosteroids
- Patients receiving treatment with any enzyme-inducing anticonvulsant
- Pregnant or nursing (lactating) women Other protocol-related inclusion/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925104
United States, Indiana | |
Indiana University Simon Cancer Center SC | |
Indianapolis, Indiana, United States, 46202 | |
Austria | |
Novartis Investigative Site | |
Salzburg, Austria, 5020 | |
Denmark | |
Novartis Investigative Site | |
Herlev, Denmark, 2730 | |
Germany | |
Novartis Investigative Site | |
Dresden, Germany, 01307 | |
Novartis Investigative Site | |
Mainz, Germany, 55131 | |
Netherlands | |
Novartis Investigative Site | |
Nijmegen, Netherlands, 6500 HB | |
Spain | |
Novartis Investigative Site | |
Malaga, Andalucia, Spain, 29010 | |
Novartis Investigative Site | |
Santiago de Compostela, Galicia, Spain, 15706 | |
Novartis Investigative Site | |
Barcelona, Spain, 08041 | |
Novartis Investigative Site | |
Madrid, Spain, 28040 | |
Novartis Investigative Site | |
Zaragoza, Spain, 50009 | |
Sweden | |
Novartis Investigative Site | |
Goteborg, Sweden, 413 45 | |
Novartis Investigative Site | |
Lund, Sweden, SE-221 85 | |
Novartis Investigative Site | |
Stockholm, Sweden, 171 76 | |
Novartis Investigative Site | |
Uppsala, Sweden, SE-751 85 | |
United Kingdom | |
Novartis Investigative Site | |
London, United Kingdom, W1G 6AD | |
Novartis Investigative Site | |
Manchester, United Kingdom, M20 4BX |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02925104 |
Other Study ID Numbers: |
CINC280A2108 2016-001829-14 ( EudraCT Number ) |
First Posted: | October 5, 2016 Key Record Dates |
Last Update Posted: | December 19, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
cMET, INC280, food, |
Neoplasms |