Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Eye Diseases

Rare Diseases

Melanoma

Uveal Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Eye Neoplasms

Uveal Diseases

Ocular Melanoma

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Twice-daily doses of AEB071 for a cycle of 28-days, given without interruption (continuous cycles)

AEB071

Twice-daily doses of MEK162 for a cycle of 28-days, given without interruption (continuous cycles)

MEK162

Pfizer CT.gov Call Center

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

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.

A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma

A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

Array Biopharma, now a wholly owned subsidiary of Pfizer

AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.

Phase Ib (Dose Escalation)

Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.

Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)

Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)

Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)

Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)

Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)

Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)

Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)

Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)

Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)

Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)

Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)

Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Hispanic or Latino

Russian

Unknown

Other

Race/Ethnicity, Customized

Netherlands

United States

United Kingdom

France

Germany

Spain

Region of Enrollment

Categories:

* 0 - Fully active, able to carry on all pre-disease performance without restriction
* 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
* 2 - Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
* 3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
* 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair

Baseline WHO Performance Status

Baseline Demographics data represents the Full Analysis Set (FAS), which includes all patients who received at least one full or partial dose of sotrastaurin or binimetinib.

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.

Study Director

Anaemia

Diarrhoea

Vomiting

Nausea

Fatigue

General Physical Health Deterioration

Malaise

Blood Creatinine Increased

Ejection Fraction Decreased

Dermatitis Acneiform

Rash

Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (DDS)

Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (DDS)

Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (DDS)

Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)

Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)

Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (DDS)

Analysis is comprised of the Dose-determining Set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1.

Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle

Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.

Phase II (Dose Expansion)

Phase II: Progression Free Survival (PFS)

Analysis group consists of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.

Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)

Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.

Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)

Complete Response

Partial Response

Stable Disease

Progressive disease

Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.

Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)

For Phase Ib, a minimum of three patients will be entered into each cohort and evaluated for safety (DLTs and any other medically significant event) at the end of Cycle 1.

Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.

Phase Ib (Dose Escalation)

Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)

Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)

Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)

Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)

Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)

Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)

Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)

Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)

Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)

Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)

Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)

Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)

This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.

Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)

Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)

Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)

Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)

Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)

Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)

Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)

Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)

Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)

Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)

Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)

Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)

Overall Study

Melanoma, Cutaneous Malignant

Patients received 4 cycles of MAGE-A3 product as follows:

* Cycle 1: 6 doses, each given at a 2-week interval,
* Cycle 2: 6 doses, each given at a 3-week interval
* Cycle 3: 4 doses, each given at a 6-week interval
* Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval.

The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides.

IM administration in the deltoid or lateral regions of the thighs, alternately on the right and left sides.

GSK Biologicals' Recombinant MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK1203486A

GSK Clinical Trials

This study is being done to evaluate the safety and the clinical activity of MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in patients with unresectable and progressive metastatic cutaneous melanoma.

MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma

Study of GSK1203486A Antigen-Specific Cancer Immunotherapeutic in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

The assessment was made as per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade refers to the severity of the AE. The CTCAE version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, as follows: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

GlaxoSmithKline

Patients received 4 cycles of MAGE-A3 product as follows: - Cycle 1: 6 doses, each given at a 2-week interval, - Cycle 2: 6 doses, each given at a 3-week interval - Cycle 3: 4 doses, each given at a 6-week interval - Cycle 4: 4 doses, each given at a 3-month interval followed by 4 doses, each given at a 6-month interval. The MAGE-A3 product was administered intramuscularly in the deltoid or lateral regions of the thighs, alternately on the right and left sides.

GSK1203486A Group

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

GSK Response Center

The Total treated cohort (TTC) included all patients who received at least one dose of the ASCI.

Number of Subjects With Any Antigen-Specific Cancer Immunotherapeutic (ASCI) Related Grade 3/4 Adverse Events (AE)

Number of Subjects With Any Serious Adverse Events (SAEs).

As the study was terminated before the end of recruitment, data was not collected.

The Rate of Objective Clinical Response.

The Rate of Stable Disease.

The Rate of Mixed Response.

Time to Study Treatment Failure.

Progression-free Survival.

Progression-free Survival After Initial SPD.

Documentation of Any Toxicity.

Immunogenicity at Defined Time Points.

LGX818

CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.

A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This includes duration of response, time to response, progression free survival and overall survival.

Baseline molecular status (mutation/ amplification/ expression) in tumor tissue of potential predictive markers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma	NCT01801358	Uveal Melanoma	AEB071 MEK162	18 Years -	Array BioPharma
MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma	NCT00706238	Melanoma	GSK Biologicals...	18 Years -	GlaxoSmithKline
MAGE-A3 Antigen-Specific Cancer Immunotherapeutic in Patients With Progressive Metastatic Cutaneous Melanoma	NCT00706238	Melanoma	GSK Biologicals...	18 Years -	GlaxoSmithKline
A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma	NCT01436656	Melanoma and Me...	LGX818	18 Years -	Pfizer

Spots Global Cancer Trial Database for melanoma,

Every month we try and update this database with for melanoma, cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for melanoma,

Every month we try and update this database with for melanoma, cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for melanoma, cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.