Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
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| ClinicalTrials.gov Identifier: NCT01324479 |
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Recruitment Status :
Completed
First Posted : March 29, 2011
Last Update Posted : April 30, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Solid Tumors | Drug: INC280 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 131 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Open-label Dose Escalation Study With Expansion to Assess the Safety and Tolerability of INC280 in Patients With c-MET Dependent Advanced Solid Tumors |
| Actual Study Start Date : | February 29, 2012 |
| Actual Primary Completion Date : | July 4, 2017 |
| Actual Study Completion Date : | July 4, 2017 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: INC280 |
Drug: INC280 |
- Incidence rate of dose-limiting toxicities and adverse events [ Time Frame: 2 years ]
- Objective response by local investigator assessment [ Time Frame: 2 years ]
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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:
- Must have evidence of c-MET dysregulation from either local data or the results of molecular pre-screening evaluations.
- Confirmed diagnosis of a solid tumor.
- Measureable lesion.
- Refractory to currently available treatment or no therapies available.
- 18 years or older.
- ECOG performance status of 0, 1, or 2.
- Obtained written informed consent.
Additional inclusion criteria for NSCLC patients EGFRwt with high c-MET expression:
- Written documentation of EGFRwt NSCLC.
- Written documentation of c-MET positivity.
- Patients should not have received more than three prior lines of antineoplastic therapy for NSCLC.
- Presence of at least one measurable lesion as determined by modified RECIST version 1.1
Exclusion Criteria:
HCC with liver dysfunction greater than Child-Pugh A. Previous treatment with a c-MET inhibitor or HGF-targeting therapy. Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control their CNS disease.
Any CNS deficits. For patients with GBM, CNS symptoms grade 2 or greater. Subjects with significant or uncontrolled cardiovascular disease (eg, uncontrolled hypertension, peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute coronary syndrome) within 6 months of starting study treatment or heart attack within 12 months of starting study treatment.
Receiving anti-epileptic drugs that are known to be strong inducers of CYP3A4. Prior or current anti-angiogenic therapy for patients with GBM. Radiation therapy within ≤ 4 weeks (< 12 for GBM) prior to the first dose of study drug or limited field radiotherapy within ≤ 2 weeks (< 12 weeks GBM) prior to the start of study treatment. Any persistent side effect of prior radiotherapy must be resolved to ≤ Grade 1 prior to the first dose of study drug.
Additional exclusion criteria for NSCLC patients EGFRwt with high c-MET expression:
- Patients who have received more than three prior lines of antineoplastic therapies
- Any unresolved toxicity (CTCAE grade > 1) from previous anti-cancer therapy or radiotherapy, except alopecia
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Patients have received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
- Conventional cytotoxic chemotherapy: ≤4 weeks (≤6 weeks for nitrosoureas and mitomycin-C)
- Biologic therapy (e.g., antibodies): ≤4 weeks
- Non-cytotoxic small molecule therapeutics: ≤5 half-lives or ≤2 weeks (whichever is longer)
- Other investigational agents: ≤4 weeks
- Radiation therapy (palliative setting is allowed.): ≤4 weeks
- Major surgery: ≤2 weeks
Other protocol-defined 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): NCT01324479
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| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01324479 |
| Other Study ID Numbers: |
CINC280X2102 2010-024101-12 ( EudraCT Number ) |
| First Posted: | March 29, 2011 Key Record Dates |
| Last Update Posted: | April 30, 2019 |
| Last Verified: | April 2019 |
| 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 |
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Non-small cell lung cancer, hepatocellular, gastric, renal cell, c-MET, |
refractory, glioblastoma, breast, nasopharyngeal, confirmed evidence of c-MET dysregulation |
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Neoplasms |