Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients

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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