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Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients

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ClinicalTrials.gov Identifier: NCT01430416
Recruitment Status : Active, not recruiting
First Posted : September 8, 2011
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Uveal Melanoma Drug: AEB071 Phase 1

Study Design
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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
Estimated Primary Completion Date : October 11, 2018
Estimated Study Completion Date : October 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: AEB071 Drug: AEB071


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation [ Time Frame: cycle 1 (28 days) ]
  2. Number of participants reporting serious adverse events and adverse events - Dose Expansion [ Time Frame: Baseline, every 28 days ]

Secondary Outcome Measures :
  1. Overall response rate (Complete Response (CR) + Partial Response(PR)) to AEB071 using RECIST version 1.1 [ Time Frame: Baseline, 12 months ]
  2. Progression free survival and time to progression using RECIST version 1.1 [ Time Frame: Baseline, 12 months ]
  3. Number of patients reporting serious adverse events and adverse events [ Time Frame: Baseline, 12 months ]
  4. AEB071/AEE800 pharmacokinetic parameters including Cmax, tmax, AUCτ, Ctrough, CL/F, and RA [ Time Frame: First 7 months of treatment period ]
  5. Gα genotype in tumor specimens [ Time Frame: Baseline, 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01430416     History of Changes
Other Study ID Numbers: COEB071X2102
2011-002535-25 ( EudraCT Number )
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Uveal melanoma
phase 1
AEB071
Metastatic

Additional relevant MeSH terms:
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