Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01430416 |
Recruitment Status :
Completed
First Posted : September 8, 2011
Last Update Posted : December 19, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uveal Melanoma | Drug: AEB071 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 153 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma |
Actual Study Start Date : | December 20, 2011 |
Actual Primary Completion Date : | May 22, 2019 |
Actual Study Completion Date : | May 22, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: AEB071 |
Drug: AEB071 |
- Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation [ Time Frame: cycle 1 (28 days) ]
- Number of participants reporting serious adverse events and adverse events - Dose Expansion [ Time Frame: Baseline, every 28 days ]
- Overall response rate (Complete Response (CR) + Partial Response(PR)) to AEB071 using RECIST version 1.1 [ Time Frame: Baseline, 12 months ]
- Progression free survival and time to progression using RECIST version 1.1 [ Time Frame: Baseline, 12 months ]
- Number of patients reporting serious adverse events and adverse events [ Time Frame: Baseline, 12 months ]
- AEB071/AEE800 pharmacokinetic parameters including Cmax, tmax, AUCτ, Ctrough, CL/F, and RA [ Time Frame: First 7 months of treatment period ]
- Gα genotype in tumor specimens [ Time Frame: Baseline, 28 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Uveal melanoma with biopsy proven metastatic disease
- Males and females ≥ 18 years of age
- Consent to biopsy of tumor
- Measurable disease according to RECIST version 1.1
- WHO performance status of ≤ 1
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:
- Cytotoxic chemotherapy: ≤ duration of the most recent cycle of the previous regimen (a minimum of 2 weeks for all)
- Nitrosurea: ≤ 6 weeks
- Biologic therapy: ≤ 4 weeks
- ≤ 5 x PK half-life of a small molecule therapeutic not otherwise defined above
- 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

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): NCT01430416
United States, Massachusetts | |
Dana Farber Cancer Institute DFCI - Brookline | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Memorial Sloan Kettering MSKCC 4 | |
New York, New York, United States, 10017 | |
France | |
Novartis Investigative Site | |
Paris, France, 75231 | |
Netherlands | |
Novartis Investigative Site | |
Leiden, Netherlands, 2300 RC | |
United Kingdom | |
Novartis Investigative Site | |
London, United Kingdom, SW3 6JJ |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01430416 |
Other Study ID Numbers: |
COEB071X2102 2011-002535-25 ( EudraCT Number ) |
First Posted: | September 8, 2011 Key Record Dates |
Last Update Posted: | December 19, 2020 |
Last Verified: | May 2020 |
Uveal melanoma phase 1 AEB071 Metastatic |
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases |