Uveal MelanomaPhase 1NCT01430416
Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients
A Phase 1 study testing AEB071 in people with Uveal Melanoma, run by Novartis Pharmaceuticals at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- AEB071
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 20 Dec 2011to 22 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
Dana Farber Cancer Institute DFCI - Brookline
Boston, Massachusetts, 02215
Memorial Sloan Kettering MSKCC 4
New York, New York, 10017
About this study
Official title: A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma
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.
- Conditions
- Uveal Melanoma
- Being tested
- AEB071
- Keywords
- Uveal melanoma, phase 1, AEB071, Metastatic
- Medical subject headings
- Uveal Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEB071Drug
| Study group | Role | What they receive |
|---|---|---|
| AEB071 | Experimental | Not described Receives: Drug: AEB071 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation
Measured: cycle 1 (28 days)
Number of participants reporting serious adverse events and adverse events - Dose Expansion
Measured: Baseline, every 28 days
Secondary outcomes (5)
Overall response rate (Complete Response (CR) + Partial Response(PR)) to AEB071 using RECIST version 1.1
Measured: Baseline, 12 months
Progression free survival and time to progression using RECIST version 1.1
Measured: Baseline, 12 months
Number of patients reporting serious adverse events and adverse events
Measured: Baseline, 12 months
AEB071/AEE800 pharmacokinetic parameters including Cmax, tmax, AUCτ, Ctrough, CL/F, and RA
Measured: First 7 months of treatment period
Gα genotype in tumor specimens
Measured: Baseline, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study start20 Dec 2011
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430416
- Sponsor's protocol ID
- COEB071X2102
- Other IDs
- 2011-002535-25
- Status last verified
- May 2020
- First submitted
- 6 Sep 2011
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT01430416
- Acronym / sponsor ID
- COEB071X2102
- Conditions
- Uveal Melanoma
- Keywords
- Uveal melanoma, phase 1, AEB071, Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2011 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AEB071 | Experimental | Drug: AEB071 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AEB071 | Drug | AEB071 |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for COEB071X2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AEB071 in people with Uveal Melanoma, run by Novartis Pharmaceuticals at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, France, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation (time frame: cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.