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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002535-25 | EudraCT Number |
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This study has two parts, dose escalation and dose expansion. For dose escalation, the primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with uveal melanoma. For dose expansion, the primary objective is to characterize the safety and tolerability of the MTD of AEB071 in patients with uveal melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AEB071 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEB071 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation | cycle 1 (28 days) | |
| Number of participants reporting serious adverse events and adverse events - Dose Expansion | Baseline, every 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (Complete Response (CR) + Partial Response(PR)) to AEB071 using RECIST version 1.1 | Baseline, 12 months | |
| Progression free survival and time to progression using RECIST version 1.1 | Baseline, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients with abnormal laboratory values as defined by the protocol
Patients who are receiving treatment with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to study entry
Patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol
Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma
Patients with impairment of gastrointestinal function or disease
Patients with severe systemic infections
Patients who are known to be HIV positive and/or have active hepatitis B or C infection
Time since last therapy for treatment of underlying malignancy:
Patients having undergone major surgery less than 4 weeks prior to enrollment or have not fully recovered from prior surgery
Women of child-bearing potential unless they are using highly effective methods of contraception during the dosing and for at least 36 hours after last dose. Highly effective contraception as defined in the protocol.
Patients with primary central nervous system tumors or brain metastases.
Pregnant or nursing (lactating) women.
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute DFCI - Brookline | Boston | Massachusetts | 02215 | United States | ||
| Memorial Sloan Kettering MSKCC 4 |
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| Label | URL |
|---|---|
| Results for COEB071X2102 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C543528 | sotrastaurin |
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| Number of patients reporting serious adverse events and adverse events | Baseline, 12 months |
| AEB071/AEE800 pharmacokinetic parameters including Cmax, tmax, AUCτ, Ctrough, CL/F, and RA | First 7 months of treatment period |
| Gα genotype in tumor specimens | Baseline, 28 days |
| New York |
| New York |
| 10017 |
| United States |
| Novartis Investigative Site | Paris | 75231 | France |
| Novartis Investigative Site | Leiden | 2300 RC | Netherlands |
| Novartis Investigative Site | London | SW3 6JJ | United Kingdom |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |