Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01430416
• Date of registration: 06/09/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
• Scientific title: A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma
• Date of first enrolment: December 20, 2011
• Target sample size: 153
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01430416
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France, Netherlands, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Uveal Melanoma

Intervention(s)

Drug: AEB071

Primary Outcome(s)

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]

Secondary Outcome(s)

AEB071/AEE800 pharmacokinetic parameters including Cmax, tmax, AUCt, Ctrough, CL/F, and RA [Time Frame: First 7 months of treatment period]

Overall response rate (Complete Response (CR) + Partial Response(PR)) to AEB071 using RECIST version 1.1 [Time Frame: Baseline, 12 months]

Ga genotype in tumor specimens [Time Frame: Baseline, 28 days]

Number of patients reporting serious adverse events and adverse events [Time Frame: Baseline, 12 months]

Progression free survival and time to progression using RECIST version 1.1 [Time Frame: Baseline, 12 months]

Secondary ID(s)

2011-002535-25

COEB071X2102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors