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Protein Kinase Inhibitor

Uprosertib + Dabrafenib + Trametinib for Advanced Skin Cancer

Q: How many establishments are overseeing this trial?

<p>This clinical trial can be found in Clackamas, <a href="https://www.withpower.com/clinical-trials/oregon">Oregon</a>; Columbus, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>; and Los Angeles <a href="https://www.withpower.com/clinical-trials/california">California</a> at their respective Radiation <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Centers, alongside 16 additional sites.</p>

Phase 1 & 2

Waitlist Available

Led By Antoni Ribas

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have BRAF^V600 mutant metastatic cancer irrespective of the histology or prior therapy; BRAF^V600 mutant status must be documented by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; use of an Food and Drug Administration (FDA)-approved test is preferred although other BRAF tests at a CLIA-certified laboratory may also be accepted

Patients must have locally advanced unresectable stage IIIC or metastatic stage IV cancer with either progression to prior therapy or a newly diagnosed cancer that does not have an available treatment with curative intent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up disease assessments every 8 weeks for up to 3 years

Awards & highlights

Study Summary

This trial is testing the effects and best dose of uprosertib when given with dabrafenib and trametinib for stage IIIC-IV cancer.

Who is the study for?

This trial is for adults with stage IIIC-IV cancer, specifically those with BRAF^V600 mutant metastatic cancer. Participants must have resolved any previous treatment side effects to a mild level and be able to take oral medication without significant gastrointestinal issues. They should not be pregnant or nursing, have active hepatitis B/C, uncontrolled illnesses like heart disease or diabetes, or a history of severe allergic reactions to similar drugs.Check my eligibility

What is being tested?

The trial is testing the combination of uprosertib with dabrafenib and trametinib in patients with advanced cancer stages. It aims to find the best dose that can block enzymes needed for tumor cell growth and determine how effective this drug combo is compared to current treatments.See study design

What are the potential side effects?

Potential side effects include but are not limited to: changes in heartbeat rhythm, high blood pressure, bleeding risks including internal bleeding, inflammation of lungs (pneumonitis), liver function changes due to hepatitis infection risk increase, vision problems such as retinal vein occlusion (RVO), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has a BRAF V600 mutation, confirmed by a certified lab.

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My cancer is advanced and cannot be surgically removed, or it has spread, and previous treatments didn’t work.

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I have had a full physical exam and medical history review in the last 28 days.

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I've had surgery before, but I've recovered from all related complications.

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I agree to give blood for drug level testing and understand the need for a specific test kit.

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I had an LDH blood test for melanoma within the last 28 days.

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I can provide tissue from when my disease worsened after BRAF inhibitor therapy or allow a new biopsy.

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My cancer's size or presence can be tracked, and has been checked recently.

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I've had a brain scan within the last 42 days and any brain cancer is stable or without symptoms.

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I am fully active and can carry on all pre-disease activities without restriction.

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I am on blood thinners and my INR levels are within the target range.

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I am a woman who can have children and have a recent negative pregnancy test.

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I've had cancer treatment before, but all side effects are now minimal.

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My heart's pumping ability is within the normal range.

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I had radiation therapy and any side effects are now mild or gone.

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I can swallow pills and don't have major stomach issues affecting medicine absorption.

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I am 18 years old or older.

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I have HIV but am not on antiviral medication and my CD4 count is 500 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ disease assessments every 8 weeks for up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~disease assessments every 8 weeks for up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and disease assessments every 8 weeks for up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum-tolerated Dose (MTD) of Akt Inhibitor GSK2141795 in Combination With Dabrafenib and Trametinib.

Maximum-tolerated Dose (MTD) of Akt Inhibitor GSK2141795 in Combination With Dabrafenib.

Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses) as Assessed by RECIST Version 1.1 of the Doublet Regimen GSK2141795 + Dabrafenib at the Phase I Determined MTD. (Phase II)

+1 more

Secondary outcome measures

Overall Survival (Phase II) of Patients Treated at the Phase I Determined MTD of Doublet Regimen

Overall Survival (Phase II) of Patients Treated at the Phase I Determined MTD of Triplet Regimen

Progression-free Survival as Assessed by RECIST Version 1.1 of the Doublet Regimen at the Phase I Determined MTD (Phase II)

+2 more

Other outcome measures

Pharmacokinetic Parameters

Prevalence of Markers

Side effects data

From 2018 Phase 2 trial • 9 Patients • NCT02281760

100%

Chills

100%

Rash

100%

Hyperthermia

100%

Anaemia

83%

Dehydration

67%

Fatigue

67%

Blood urea increased

67%

Lipase increased

67%

Headache

50%

Nausea

50%

Blood creatinine increased

50%

Blood cholesterol increased

50%

Hyponatraemia

50%

Diarrhoea

50%

Back pain

50%

Pain in extremity

50%

Amylase increased

50%

Blood creatine phosphokinase increased

33%

Dyspepsia

33%

Aspartate aminotransferase increased

33%

Blood pressure increased

33%

Myalgia

33%

Red blood cells urine

33%

Alanine aminotransferase increased

33%

Hypotension

33%

Labile hypertension

33%

Hypertension

33%

Hypertriglyceridaemia

33%

Blood alkaline phosphatase increased

33%

Ataxia

33%

Abdominal pain

33%

Urinary tract infection

33%

Cough

33%

Malaise

33%

Vomiting

33%

Disturbance in attention

17%

Arthralgia

17%

Syncope

17%

Vertigo

17%

Arthritis

17%

Penile pain

17%

Gamma-glutamyltransferase increased

17%

Memory impairment

17%

Gingival recession

17%

Paronychia

17%

Viral infection

17%

Prothrombin time prolonged

17%

Leukopenia

17%

Erythema nodosum

17%

Hypernatraemia

17%

Sweating fever

17%

Hyperglycaemia

17%

Lip dry

17%

Lymphadenopathy

17%

Acute kidney injury

17%

Pharyngitis

17%

Urosepsis

17%

Nasal congestion

17%

Hypomagnesaemia

17%

Blood thyroid stimulating hormone decreased

17%

Cystatin C increased

17%

Anorexia nervosa

17%

Skin sensitisation

17%

Joint effusion

17%

Confusional state

17%

Proteinuria

17%

Dyspnoea

17%

Hyperuricaemia

100%

80%

60%

40%

20%

Study treatment Arm

Combination Therapy With Dabrafenib and Trametinib in Patients With ECD

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (uprosertib, dabrafenib, trametinib)Experimental Treatment7 Interventions

Dabrafenib mesylate and uprosertib (Phase I): Patients receive dabrafenib PO BID and uprosertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, and blood sample collection throughout trial. Patients may also undergo a biopsy throughout the trial. Dabrafenib mesylate, trametinib dimethyl sulfoxide, and uprosertib (Phase I and Phase II): Patients receive dabrafenib PO BID, trametinib PO QD, and uprosertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, and blood sample collection throughout trial. Patients may also undergo a biopsy throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~850

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Dabrafenib Mesylate

2014

Completed Phase 2

~10

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Trametinib Dimethyl Sulfoxide

2014

Completed Phase 2

~10

Uprosertib

2013

Completed Phase 2

~100

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,126 Total Patients Enrolled

4 Trials studying Cutaneous Melanoma

198 Patients Enrolled for Cutaneous Melanoma

GlaxoSmithKlineIndustry Sponsor

4,750 Previous Clinical Trials

8,067,425 Total Patients Enrolled

Novartis PharmaceuticalsIndustry Sponsor

2,855 Previous Clinical Trials

4,197,323 Total Patients Enrolled

1 Trials studying Cutaneous Melanoma

180 Patients Enrolled for Cutaneous Melanoma

Media Library

Dabrafenib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01902173 — Phase 1 & 2

Cutaneous Melanoma Research Study Groups: Treatment (uprosertib, dabrafenib, trametinib)

Cutaneous Melanoma Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT01902173 — Phase 1 & 2

Dabrafenib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01902173 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has Dabrafenib Mesylate been subject to medical investigation?

"Dabrafenib Mesylate was initially examined in 2012 at the University of Chicago Medical Center, and has since accumulated 89 total completed studies. Presently, 95 active trials are underway with a major portion occurring around Clackamas, Oregon."

Answered by AI

To what extent is enrollment being accepted for this investigation?

"Currently, enrollment in this trial has been closed. It was initially posted on July 19th 2013 and lastly updated on July 27th 2022. For other potential studies, there are 3132 trials for melanoma and 95 clinical tests involving Dabrafenib Mesylate that still accept participants."

Answered by AI

Are more participants being sought for this medical trial?

"Per clinicaltrials.gov, this trial has ceased recruitment of new participants. Originally posted on 19th July 2013 and last updated 27th July 2022, it is no longer enrolling participants but there are still 3227 other medical trials actively recruiting patients at present."

Answered by AI

How many establishments are overseeing this trial?

"This clinical trial can be found in Clackamas, Oregon; Columbus, Ohio; and Los Angeles California at their respective Radiation Oncology Centers, alongside 16 additional sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer

2013. "Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01902173.

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