A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02925104
• Collaborator: (none)
• Enrollment: 36
• Locations: 17
• Arm: 1
• Actual Duration (Months): 17
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.

Condition or Disease	Intervention/Treatment	Phase
cMET Dysegulation Advanced Solid Tumors	Drug: INC280	Phase 1

Study Design

• Study Type: Interventional
• 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: Dec 14, 2016
• Actual Primary Completion Date: May 16, 2018
• Actual Study Completion Date: May 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INC280	Drug: INC280

Outcome Measures

Primary Outcome Measures

1. Incidence of Dose limiting toxiticites (DLTs) [During the first 28 days on INC280 treatment; cycle = 21 days]

2. Frequency of DLTs [During the first 28 days on INC280 treatment]

3. Category of DLTs [During the first 28 days on INC280 treatment]

4. AUClast for INC280 [Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1]

5. AUCtau for INC280 [C1D1, C1D7, C1D15, C2D1, C3D1]

6. Cmax for INC280 [C1D1, C1D7, C1D15, C2D1, C3D1]

7. Tmax [C1D1, C1D7, C1D15, C2D1, C3D1]

Secondary Outcome Measures

1. Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results). [Screening, until 30 days post-treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Simon Cancer Center SC	Indianapolis	Indiana	United States	46202
2	Novartis Investigative Site	Salzburg		Austria	5020
3	Novartis Investigative Site	Herlev		Denmark	2730
4	Novartis Investigative Site	Dresden		Germany	01307
5	Novartis Investigative Site	Mainz		Germany	55131
6	Novartis Investigative Site	Nijmegen		Netherlands	6500 HB
7	Novartis Investigative Site	Malaga	Andalucia	Spain	29010
8	Novartis Investigative Site	Santiago de Compostela	Galicia	Spain	15706
9	Novartis Investigative Site	Barcelona		Spain	08041
10	Novartis Investigative Site	Madrid		Spain	28040
11	Novartis Investigative Site	Zaragoza		Spain	50009
12	Novartis Investigative Site	Goteborg		Sweden	413 45
13	Novartis Investigative Site	Lund		Sweden	SE-221 85
14	Novartis Investigative Site	Stockholm		Sweden	171 76
15	Novartis Investigative Site	Uppsala		Sweden	SE-751 85
16	Novartis Investigative Site	London		United Kingdom	W1G 6AD
17	Novartis Investigative Site	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results for CINC280A2108 can be found on the Novartis Clinical Trial Results Website

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02925104
• Other Study ID Numbers: CINC280A2108; 2016-001829-14
• First Posted: Oct 5, 2016
• Last Update Posted: Dec 19, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: cMET, INC280, food,
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Dec 19, 2020