Brief Title
Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
Official Title
A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma
Brief Summary
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation
Secondary Outcome
Overall response rate (Complete Response (CR) + Partial Response(PR)) to AEB071 using RECIST version 1.1
Condition
Uveal Melanoma
Intervention
AEB071
Study Arms / Comparison Groups
AEB071
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
153
Start Date
December 20, 2011
Completion Date
May 22, 2019
Primary Completion Date
May 22, 2019
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01430416
Organization ID
COEB071X2102
Secondary IDs
2011-002535-25
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
May 2020