MelanomaPhase 1NCT02447939

Pharmacokinetics of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib and Trametinib in Chinese Subjects With Melanoma

A Phase 1 study testing Dabrafenib and Trametinib in people with Melanoma, run by GlaxoSmithKline.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma
What is being tested?: Dabrafenib and Trametinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: May 2017to Dec 2018
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

Provided signed written informed consent.
Males and females >=18 years of age.
Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and BRAF V600E/K mutation-positive from the designated qualified laboratory for this study.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate baseline organ function defined by: Absolute neutrophil count (ANC): >=1,200 /microliter (uL); Hemoglobin: >=9 grams (g)/deciliter (dL); Platelets: >=100,000 /uL; Prothrombin time/ International normalization ratio and activated partial thromboplastin time: <=1.3 x Upper Limit of Normal (ULN); Total bilirubin: <=1.5 x ULN; Aspartate aminotransferase and Alanine aminotransferase: <=2.5 x ULN; Calculated creatinine clearance (Calculate creatinine clearance using standard Cockcroft-Gault formula): >=50 milliliter (mL)/ minute (min) or 24-hour urine creatinine clearance>=50 mL/min; Left ventricular Ejection fraction (LVEF): >/= 50% LVEF in case there is no established Lower limit of normal (LLN) for a given institution.

Who cannot join

Prior treatment with a BRAF inhibitor or a MEK inhibitor
Pregnant or Lactating female.
History of another malignancy. Subjects with any previous malignancy with confirmed activating RAS mutation at any time are not eligible. Note: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility. Exception: Subjects who have been disease-free for 5 years (except those with confirmed activating RAS mutations), or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Brain metastasis are excluded unless: All known lesions have been definitively treated with surgery or stereotactic surgery (whole-brain radiation may be given as adjuvant treatment), OR Brain lesion(s), if still present, must be confirmed stable (i.e., no increase in lesion size) for >=12 weeks prior to enrollment (stability must be confirmed with two consecutive magnetic resonance image (MRI) or computed tomography (CT) scans with contrast, separated by >6 weeks AND Asymptomatic with no corticosteroid requirements for >=4 weeks prior to enrollment, AND No enzyme inducing anticonvulsants for >=2 weeks prior to enrollment. In addition, for subjects that had brain metastases but currently have no evidence of disease (NED), NED for >=12 weeks is required and must be confirmed by two consecutive scans, separated by >=6 weeks, prior to enrollment.
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to enrolment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrolment.

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Any prohibited medication(s).
Administration of an investigational study treatment within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment(s) in this study.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO).
A history or evidence of cardiovascular risk including any of the following: Current LVEF < Institutional LLN; a QTc interval corrected for heart rate >=480 millisecond (msec) (using Bazett's formula); a history or evidence of current clinically significant uncontrolled arrhythmias; Exception: Subjects with atrial fibrillation controlled for >30 days prior to enrollment are eligible; a history (within 6 months prior to enrollment) of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty; a history or evidence of current >=Class II congestive heart failure as defined by the New York Heart Association (NYHA) guidelines; treatment refractory hypertension defined as a blood pressure of systolic>140 millimeters of mercury (mmHg) and/or diastolic >90 mm Hg which cannot be controlled by anti-hypertensive therapy; subjects with intra-cardiac defibrillators; abnormal cardiac valve morphology (>=Grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
Uncorrectable electrolyte abnormalities (e.g. hypokalaemia, hypomagnesaemia, hypocalcaemia determined by blood chemistry), long QT syndrome or taking medicinal products known to prolong the QT interval.
A history of retinal vein occlusion (RVO)
History of interstitial lung disease or pneumonitis.
History of HIV infection.
History of Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
Subjects with laboratory evidence of cleared HBV and/or HCV will be permitted, which defined as HBs antigen negative and HBV Deoxyribonucleic acid (DNA) negative; and HCV antibody is negative.

About this study

Official title: A Phase I Study to Evaluate the Pharmacokinetics and Safety of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib With Trametinib in Chinese Subjects With Melanoma

Present clinical study will be conducted in China to evaluate the pharmacokinetics (PK) of single and repeat oral doses of dabrafenib alone and dabrafenib and trametinib in combination, the safety profile and the clinical activity of dabrafenib in combination with trametinib in Chinese melanoma subjects with BRAF V600E/K mutation. Approximately 20 evaluable subjects will be enrolled in the study, out of which, the first 10 subjects will be enrolled into cohort A (Part I and II) and remaining 10 subjects will be enrolled in cohort B. Subjects in cohort A (Part I) will receive dabrafenib 150 mg twice daily (BID) and subjects in cohort A (Part II) and Cohort B will receive combination of dabrafenib 150 mg BID and trametinib 2 mg once daily (QD). Study treatment will continue until disease progression, death or unacceptable toxicity. After disease progression, all enrolled subjects will be followed up for overall survival. The study will be completed after all subjects have died or surviving subjects have had at least 5 years of follow-up, whichever occurs first.

Conditions: Melanoma
Being tested: Dabrafenib, Trametinib
Keywords: pharmacokinetics, trametinib, cutaneous melanoma, dabrafenib, safety
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DabrafenibDrug
Dabrafenib will be provided as 50 mg and 75 mg capsules. Each capsule will contain 50 mg or 75 mg of free base (present as the mesylate salt).
TrametinibDrug
Trametinib study will be provided as 0.5 mg and 2.0 mg tablets. Each tablet will contain 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)

Study groups in NCT02447939
Study group	Role	What they receive
Dabrafenib and Trametinib	Experimental	Subject will be assigned in 2 cohorts, in cohort A, subjects will be administered dabrafenib (150 mg BID) monotherapy from Day1 to Day 21 (first part), followed by dabrafenib (150 mg BID) and trametinib (2mg QD) combination (second part, starting from day 22). After the last subject in cohort A has finished the last pharmacokinetic sampling(1st part ), another 10 subjects will be enrolled in cohort B with administration of dabrafenib (150 mg BID) in combination with oral trametinib (2mg QD). Receives: Drug: Dabrafenib; Drug: Trametinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose: Cmax,Tmax and AUC(0-tau)
Maximum observed plasma concentration (Cmax), time to Cmax (Tmax) and area under the concentration-time curve over the dosing interval [AUC(0-tau)] will be calculated for dabrafenib and its metabolites.
Measured: At Day 1: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
A Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose : Tmax, Css_min, Css_max, Css_av and AUC(0-tau)
Tmax, minimum concentration at steady state (Css_min), maximum concentration at steady state (Css_max), average concentration at steady state (Css_av), AUC(0-tau) will be calculated for dabrafenib and its metabolites.
Measured: At Day 21: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Accumulation ratio of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose
Measured: At Day 21.
Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose: Cmax, Tmax, AUC(0-tau)
Measured: At Day 1: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose : Tmax, Css_min, Css_max, Css_av, AUC(0-tau)
Measured: At Day 21: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Accumulation ratio of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose
Measured: At Day 21.
Composite of PK parameters of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose: Cmax, Tmax, AUC(0-tau)
Measured: At Day 1: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Composite of PK parameters of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose : Tmax, Css_min, Css_max, Css_av, AUC(0-tau)
Measured: At Day 21: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Accumulation ratio of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose
Measured: At Day 21.
Effective half-life of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose
Measured: At Day 21.

Secondary outcomes (13)

Composite of Physical examination assessment
Physical examination will include assessments of eyes, neurological and cardiovascular systems, lungs, abdomen, head, neck, ears, nose, mouth, throat, thyroid, lymph nodes, extremities, and skin, genitourinary (pelvic) and rectal exams.
Measured: Up to 30 days of the subject's last dose (assessed up to 5 years).
Composite of Safety and tolerability as assessed by vital signs assessment: blood pressure, temperature and pulse rate
Vital sign measurements will include systolic and diastolic blood pressure, body temperature and pulse rate.
Measured: Up to 30 days of the subject's last dose (assessed up to 5 years).
Electrocardiogram (ECG) assessment
12-lead ECGs will be obtained at each time point using an ECG machine that automatically to calculate the heart rate and measures PR, QRS, QT and corrected QT interval duration (QTc intervals).
Measured: Up to 30 days of the subject's last dose (assessed up to 5 years).
Echocardiogram (ECHO) assessment
ECHO assessment will include an evaluation for left ventricular ejection fraction.
Measured: At week 4, week 8, and then every 8 weeks until treatment discontinuation.
Eye exams assessment
Eye exam will include indirect fundoscopic examination,visual acuity, visual field examination, and tonometry, with special attention to retinal abnormalities.
Measured: At screening, and when clinical indicated until treatment discontinuation.
Chemistry laboratory values assessment
Measured: Up to 30 days of the subject's last dose (assessed up to 5 years).
Number of subjects with Adverse events (AEs)
Measured: Up to 5 years.
Number of subjects with Serious Adverse events (SAEs)
Measured: Up to 5 years.
Objective response rate (ORR)
ORR defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation
Measured: Up to 5 years.
Progression free survival(PFS)
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Measured: Up to 5 years.
Overall survival(OS)
OS defined as the interval from first dose of study treatment to the date of death, irrespective of the cause of death; subjects still alive will be censored at the date of the last contact.
Measured: Up to 5 years.
Hematology laboratory values assessment
Measured: Up to 30 days of the subject's last dose (assessed up to 5 years).
Urinalysis laboratory values assessment
Measured: Up to 30 days of the subject's last dose (assessed up to 5 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2017Dec 2018

First posted19 May 2015 (estimated)
Study startMay 2017 (estimated)
Primary completionOct 2018 (estimated)
Study completionDec 2018 (estimated)

Why it stopped: Change in strategy

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MelanomaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02447939
Sponsor's protocol ID: 201020
Status last verified: Jan 2017
First submitted: 7 May 2015
Last updated: 14 Sep 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Evaluate the Pharmacokinetics and Safety of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib With Trametinib in Chinese Subjects With Melanoma
ClinicalTrials.gov ID: NCT02447939
Acronym / sponsor ID: 201020
Conditions: Melanoma
Keywords: pharmacokinetics, trametinib, cutaneous melanoma, dabrafenib, safety
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Change in strategy
Enrolment: 0 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2017 (estimated)
Primary completion: Oct 2018 (estimated)
Study completion: Dec 2018 (estimated)
First posted: 19 May 2015 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dabrafenib and Trametinib	Experimental	Drug: Dabrafenib, Drug: TrametinibSubject will be assigned in 2 cohorts, in cohort A, subjects will be administered dabrafenib (150 mg BID) monotherapy from Day1 to Day 21 (first part), followed by dabrafenib (150 mg BID) and trametinib (2mg QD) combination (second part, starting from day 22). After the last subject in cohort A has finished the last pharmacokinetic sampling(1st part ), another 10 subjects will be enrolled in cohort B with administration of dabrafenib (150 mg BID) in combination with oral trametinib (2mg QD).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provided signed written informed consent.
Males and females >=18 years of age.
Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and BRAF V600E/K mutation-positive from the designated qualified laboratory for this study.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate baseline organ function defined by: Absolute neutrophil count (ANC): >=1,200 /microliter (uL); Hemoglobin: >=9 grams (g)/deciliter (dL); Platelets: >=100,000 /uL; Prothrombin time/ International normalization ratio and activated partial thromboplastin time: <=1.3 x Upper Limit of Normal (ULN); Total bilirubin: <=1.5 x ULN; Aspartate aminotransferase and Alanine aminotransferase: <=2.5 x ULN; Calculated creatinine clearance (Calculate creatinine clearance using standard Cockcroft-Gault formula): >=50 milliliter (mL)/ minute (min) or 24-hour urine creatinine clearance>=50 mL/min; Left ventricular Ejection fraction (LVEF): >/= 50% LVEF in case there is no established Lower limit of normal (LLN) for a given institution.

Key exclusion criteria (16 listed)

Prior treatment with a BRAF inhibitor or a MEK inhibitor
Pregnant or Lactating female.
History of another malignancy. Subjects with any previous malignancy with confirmed activating RAS mutation at any time are not eligible. Note: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility. Exception: Subjects who have been disease-free for 5 years (except those with confirmed activating RAS mutations), or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
Brain metastasis are excluded unless: All known lesions have been definitively treated with surgery or stereotactic surgery (whole-brain radiation may be given as adjuvant treatment), OR Brain lesion(s), if still present, must be confirmed stable (i.e., no increase in lesion size) for >=12 weeks prior to enrollment (stability must be confirmed with two consecutive magnetic resonance image (MRI) or computed tomography (CT) scans with contrast, separated by >6 weeks AND Asymptomatic with no corticosteroid requirements for >=4 weeks prior to enrollment, AND No enzyme inducing anticonvulsants for >=2 weeks prior to enrollment. In addition, for subjects that had brain metastases but currently have no evidence of disease (NED), NED for >=12 weeks is required and must be confirmed by two consecutive scans, separated by >=6 weeks, prior to enrollment.
Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.

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
DabrafenibDabrafenib will be provided as 50 mg and 75 mg capsules. Each capsule will contain 50 mg or 75 mg of free base (present as the mesylate salt).	Drug	Dabrafenib and Trametinib
TrametinibTrametinib study will be provided as 0.5 mg and 2.0 mg tablets. Each tablet will contain 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)	Drug	Dabrafenib and Trametinib

Primary outcome

Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose: Cmax,Tmax and AUC(0-tau)
Time frame: At Day 1: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Maximum observed plasma concentration (Cmax), time to Cmax (Tmax) and area under the concentration-time curve over the dosing interval [AUC(0-tau)] will be calculated for dabrafenib and its metabolites.
A Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose : Tmax, Css_min, Css_max, Css_av and AUC(0-tau)
Time frame: At Day 21: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Tmax, minimum concentration at steady state (Css_min), maximum concentration at steady state (Css_max), average concentration at steady state (Css_av), AUC(0-tau) will be calculated for dabrafenib and its metabolites.
Accumulation ratio of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose
Time frame: At Day 21.
Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose: Cmax, Tmax, AUC(0-tau)
Time frame: At Day 1: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose : Tmax, Css_min, Css_max, Css_av, AUC(0-tau)
Time frame: At Day 21: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Accumulation ratio of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose
Time frame: At Day 21.
Composite of PK parameters of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose: Cmax, Tmax, AUC(0-tau)
Time frame: At Day 1: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Composite of PK parameters of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose : Tmax, Css_min, Css_max, Css_av, AUC(0-tau)
Time frame: At Day 21: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.
Accumulation ratio of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose
Time frame: At Day 21.
Effective half-life of trametinib following single and repeat dabrafenib (150 mg BID) and trametinib (2 mg QD) dose
Time frame: At Day 21.

13 secondary outcomes

Composite of Physical examination assessment
Time frame: Up to 30 days of the subject's last dose (assessed up to 5 years).
Composite of Safety and tolerability as assessed by vital signs assessment: blood pressure, temperature and pulse rate
Time frame: Up to 30 days of the subject's last dose (assessed up to 5 years).
Electrocardiogram (ECG) assessment
Time frame: Up to 30 days of the subject's last dose (assessed up to 5 years).
Echocardiogram (ECHO) assessment
Time frame: At week 4, week 8, and then every 8 weeks until treatment discontinuation.
Eye exams assessment
Time frame: At screening, and when clinical indicated until treatment discontinuation.
Chemistry laboratory values assessment
Time frame: Up to 30 days of the subject's last dose (assessed up to 5 years).
Number of subjects with Adverse events (AEs)
Time frame: Up to 5 years.
Number of subjects with Serious Adverse events (SAEs)
Time frame: Up to 5 years.
Objective response rate (ORR)
Time frame: Up to 5 years.
Progression free survival(PFS)
Time frame: Up to 5 years.
Overall survival(OS)
Time frame: Up to 5 years.
Hematology laboratory values assessment
Time frame: Up to 30 days of the subject's last dose (assessed up to 5 years).
Urinalysis laboratory values assessment
Time frame: Up to 30 days of the subject's last dose (assessed up to 5 years).

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dabrafenib and Trametinib in people with Melanoma, run by GlaxoSmithKline.

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 16 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: withdrawn, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Composite of PK parameters of dabrafenib and its metabolites following single and repeat dabrafenib (150 mg BID) dose: Cmax,Tmax and AUC(0-tau) (time frame: At Day 1: Pre dose, 1,2, 3, 4, 6, 8, 12 and 24 h post dose.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02447939.

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 14 Sep 2018.