Uveal MelanomaPhase 1/2NCT01801358
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
A Phase 1/2 study testing AEB071 and MEK162 in people with Uveal Melanoma, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 7 sites in 6 countries.
Trial summary
A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. 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 and MEK162
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Aug 2013to May 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent
- Male and female patients aged 18 years or older
- A history of uveal (ocular) melanoma with biopsy-confirmed metastatic disease
- Consent to providing 3 tumor biopsy samples throughout the course of the study
- Presence of measurable disease
- A WHO performance status of less than or equal to 1
Who cannot join
- Presence of CNS lesions (stable lesions may be acceptable)
- Previous or concurrent malignancy, other than basal cell or squamous cell carcinoma of the skin: in situ carcinoma of the cervix, without evidence of recurrence for at least 3 years; a primary malignancy completely resected and no evidence of recurrence for at least 3 years
- Adverse event from prior chemotherapy, radiotherapy or surgery that has not recovered to CTCAE v4.03 Grade 1 or less, except for alopecia/sensory peripheral neuropathy, which must be less than Grade 2
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
- Impaired cardiac function or clinically significant cardiac disease
- Impaired GI function or disease that could interfere with the absorption of AEB071 and/or MEK162
Show all 10Show fewer
- Treatment with medicines or herbal supplements that are known inhibitors or inducers of CYP3A4/5 and cannot be withdrawn prior to study treatment
- Females of child-bearing potential who are unwilling or unable to use highly effective means of contraception
- Males who are unwilling or unable to use a condom during sexual intercourse
- Prior exposure to a MEK or PKC inhibitor Other inclusion/exclusion criteria apply
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
United States2 sites
Dana Farber Cancer Institute Dept. Onc
Boston, Massachusetts, 02215
Memorial Sloan Kettering Cancer Center Dept of Onc..
New York, New York, 90033
About this study
Official title: A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
Read the detailed description
Due to halted enrollment, the Phase II part of the study was not conducted. The Sponsor decided to permanently stop recruitment for the study prior to MTD determination.
Remaining patients on treatment with binimetinib and sotrastaurin who were considered by the Investigator to be benefiting from their treatment could have continued treatment and were to be followed up as per protocol. No patients were ongoing as of the data cut-off date. After the last patient last visit (LPLV) was declared, the study was terminated.
- Conditions
- Uveal Melanoma
- Being tested
- AEB071, MEK162
- Keywords
- Melanoma,, melanoma of the eye,, uveal,, MEK162,, AEB071
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEB071Drug
Also called Sotrastaurin
Twice-daily doses of AEB071 for a cycle of 28-days, given without interruption (continuous cycles)
MEK162Drug
Twice-daily doses of MEK162 for a cycle of 28-days, given without interruption (continuous cycles)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | AEB071 and MEK162 combined Receives: Drug: AEB071; Drug: MEK162 |
| Arm B | Experimental | MEK162 alone Receives: Drug: MEK162 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.
Measured: Cycle 1 (up to 28 days)
Phase II: Progression Free Survival (PFS)
The time from date of randomization to the date of event defined as the first documented progression or death due to any cause.
Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.
Measured: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Secondary outcomes (21)
Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
Measured: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)
Serious adverse event (SAE) is defined as one of the following:
- Is fatal or life-threatening
- Results in persistent or significant disability/incapacity
- Constitutes a congenital anomaly/birth defect
- Is medically significant
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Note that hospitalizations for the following reasons should not be reported as serious adverse events:
- Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition
- Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent
- Social reasons and respite care in the absence of any deterioration in the patient's general condition
Measured: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Measured: Cycle 1 (up to 28 days)
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
Duration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study.
Measured: Cycle 1 (up to 28 days)
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.
Measured: Cycle 1 (up to 28 days)
Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as 'Objective response rate' in some protocols or publications.
Due to an enrollment halt, the Phase II part of the study was not conducted.
Measured: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Due to an enrollment halt, the Phase II part of the study was not conducted.
Measured: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Duration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study.
Measured: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause.
Due to an enrollment halt, the Phase II part of the study was not conducted.
Measured: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 1)
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 1)
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 1)
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 15)
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 15)
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 15)
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 1)
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 1)
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 1)
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 15)
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 15)
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Measured: Cycle 1 (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: The trial was terminated for scientific reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801358
- Sponsor's protocol ID
- CMEK162X2203
- Status last verified
- Sep 2020
- First submitted
- 21 Feb 2013
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT01801358
- Acronym / sponsor ID
- CMEK162X2203
- Conditions
- Uveal Melanoma
- Keywords
- Melanoma,, melanoma of the eye,, uveal,, MEK162,, AEB071
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated for scientific reasons.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Posted 20 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
Detailed description
Due to halted enrollment, the Phase II part of the study was not conducted. The Sponsor decided to permanently stop recruitment for the study prior to MTD determination.
Remaining patients on treatment with binimetinib and sotrastaurin who were considered by the Investigator to be benefiting from their treatment could have continued treatment and were to be followed up as per protocol. No patients were ongoing as of the data cut-off date. After the last patient last visit (LPLV) was declared, the study was terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AEB071, Drug: MEK162AEB071 and MEK162 combined |
| Arm B | Experimental | Drug: MEK162MEK162 alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- Male and female patients aged 18 years or older
- A history of uveal (ocular) melanoma with biopsy-confirmed metastatic disease
- Consent to providing 3 tumor biopsy samples throughout the course of the study
- Presence of measurable disease
Key exclusion criteria (10 listed)
- Presence of CNS lesions (stable lesions may be acceptable)
- Previous or concurrent malignancy, other than basal cell or squamous cell carcinoma of the skin: in situ carcinoma of the cervix, without evidence of recurrence for at least 3 years; a primary malignancy completely resected and no evidence of recurrence for at least 3 years
- Adverse event from prior chemotherapy, radiotherapy or surgery that has not recovered to CTCAE v4.03 Grade 1 or less, except for alopecia/sensory peripheral neuropathy, which must be less than Grade 2
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
- Impaired cardiac function or clinically significant cardiac 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 |
|---|---|---|
| AEB071Also: SotrastaurinTwice-daily doses of AEB071 for a cycle of 28-days, given without interruption (continuous cycles) | Drug | Arm A |
| MEK162Twice-daily doses of MEK162 for a cycle of 28-days, given without interruption (continuous cycles) | Drug | Arm A, Arm B |
Primary outcome
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Time frame: Cycle 1 (up to 28 days)
A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.
Phase II: Progression Free Survival (PFS)
Time frame: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
The time from date of randomization to the date of event defined as the first documented progression or death due to any cause. Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.
21 secondary outcomes
Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)
Time frame: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)
Time frame: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Time frame: Cycle 1 (up to 28 days)
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)
Time frame: Cycle 1 (up to 28 days)
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)
Time frame: Cycle 1 (up to 28 days)
Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)
Time frame: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Time frame: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)
Time frame: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)
Time frame: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)
Time frame: Cycle 1 (Day 1)
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)
Time frame: Cycle 1 (Day 1)
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)
Time frame: Cycle 1 (Day 1)
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)
Time frame: Cycle 1 (Day 15)
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)
Time frame: Cycle 1 (Day 15)
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)
Time frame: Cycle 1 (Day 15)
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)
Time frame: Cycle 1 (Day 1)
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)
Time frame: Cycle 1 (Day 1)
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)
Time frame: Cycle 1 (Day 1)
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)
Time frame: Cycle 1 (Day 15)
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)
Time frame: Cycle 1 (Day 15)
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)
Time frame: Cycle 1 (Day 15)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pfizer CT.gov Call Center study director
Pfizer
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AEB071 and MEK162 in people with Uveal Melanoma, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 7 sites in 6 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, France, Germany, Netherlands, Spain and 1 more country. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle (time frame: Cycle 1 (up to 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 16 Sep 2020.