CancerPhase 2NCT05876806
Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations
A Phase 2 study testing Dabrafenib and Trametinib in people with Cancer, run by Se Jun Park at 1 site in South Korea.
Trial summary
This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with solid tumors with BRAF V600E mutation or clinically actionable BRAF gene alterations. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer
- 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
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2023to Mar 2026
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all the following criteria for study entry:
- Patient who agreed to participate in the KOSMOS-II master observation study
- 19 years of age or older
- Patients with BRAF V600 mutated advanced solid tumor (excluding BRAF V600E/K mutated malignant melanoma, BRAF V600E mutated non-small cell lung cancer, and BRAF V600E mutated colorectal cancer)
- Patients with other BRAF gene alterations that are regarded to be actionable by the KOSMOS MTB
- Disease progression after ≥ 1-prior line of systemic treatment and no standard treatment option
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- ECOG performance status score 0-2
- Life expectancy of > 3 months
- Measurable or evaluable disease according to RECIST version 1.1
- Ability to take oral medications
- Adequate bone marrow and organ function
- Patients who voluntarily decided to participate after understanding this clinical trial, and signed a written informed consent
Who cannot join
- Subjects who meet any of the following criteria will be excluded from study entry:
- Prior treatment with a BRAF inhibitor (including, but not limited to, dabrafenib, vemurafenib, encorafenib) or MEK inhibitor (including, but not limited to, trametinib, binimetinib, selumetinib, cobimetinib) or ERK inhibitor (including, but not limited to, ravoxertinib, ulixertinib, CC-90003, MK-8353)
- History of malignancies with confirmed activating RAS mutation.
- Hypersensitivity to the active ingredients and additives of investigational product.
- Presence of any unresolved ≥Grade 2 (per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) toxicity from previous anti-cancer therapy at the time of enrollment. (Except toxicities which are not clinically significant such as alopecia, skin discoloration, and neuropathy).
- Any anti-cancer treatment (local treatment, chemotherapy, immunotherapy, targeted therapy) within 2 weeks prior to the start of study treatment.
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- Prior major surgery less than 14 days before enrollment. Any surgery-related AE must have been resolved before enrollment.
- Prior radiotherapy less than 14 days before enrollment, except for ATC (radiotherapy is not permitted within 7 days before enrollment).
- Known additional malignancy that is progressing or has required active treatment within the past 3 years. (Patient with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is potentially eligible).
- Presence of central nervous system metastases that are symptomatic or untreated or not stable for ≥3 months or requiring corticosteroids.
- Symptomatic or untreated leptomeningeal or spinal cord compression. Subjects who have been previously treated for these conditions are asymptomatic and currently not taking corticosteroids before enrollment, is permitted.
- Current evidence of cardiovascular risk including any of the following:
- Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal
- QT interval corrected for heart rate using Bazett's formula ≥ 480 msec
- Clinically significant uncontrolled arrhythmias
- Moderate valvular thickening documented by echocardiography
- Presence of intra-cardiac defibrillators
- Acute coronary syndromes (including myocardial infarction and unstable angina) which required coronary angioplasty or stenting within 6 months before enrollment
- Congestive heart failure ≥ Class II as defined by New York Heart Association
- Current evidence or history of retinal vein occlusion
- Pregnant or lactating women
- Patients who do not consent to adequate contraception throughout the study period
- Women of childbearing potential should use effective contraception* until 16 weeks after the last investigational product administration
- Male patients who have not undergone a vasectomy must consent to the use of appropriate contraception* and are prohibited from providing sperm for up to 16 weeks after administration of the last investigational product * Appropriate contraception: hormonal contraceptives (subcutaneous formulas, injections, oral contraceptives, etc.), intrauterine devices (IUD, Intra Uterine Device or IUS, Intra Uterine System), sterilization by participants or participant's partner (vasectomy, tubal ligation, etc.); Double blocking (a method that uses a combination of blocking methods, such as using a cervical cap or a contraceptive diaphragm with a male condom)
- Active infection such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- For HBsAg is positive, and HBV DNA ≤ LLOQ, enrollment of the subject can be considered.
- If the patient with chronic hepatitis B who are HBsAg positive and HBV DNA positive has been taking antiviral drugs for more than 3 months, enrollment of the subject can be considered at the investigator's discretion.
- For IgG anti-HBc is positive (a history of HBV infection) and HBV DNA ≤ LLOQ, enrollment of the subject can be considered.
- For Anti-HCV Ab is positive, and HCV RNA ≤ LLOQ, enrollment of the subject can be considered.
- Acute/chronic medical or psychiatric abnormalities
- The investigator judges that it is not appropriate to participate in this study for else reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 06591
Se Jun Park, MD. PhD
About this study
Official title: A Phase II, Open-label Study of Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations
This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with solid tumors with BRAF V600E mutation or clinically actionable BRAF gene alterations.
Read the detailed description
Dabrafenib and trametinib combination treatment can offer a therapeutic option for patients with solid cancers harboring specific gene mutations, for whom there are no alternative treatments.
Patients with BRAF V600 mutated advanced solid tumor (excluding BRAF V600E/K mutated malignant melanoma, BRAF V600E mutated non-small cell lung cancer, and BRAF V600E mutated colorectal cancer) or patients with other BRAF gene alterations that are regarded to be druggable by the KOSMOS MTB.
This study is designed to determine the disease control rate (DCR) of oral Dabrafenib in combination with oral Trametinib in subjects with BRAF V600E or clinically actionable BRAF mutated cancers. Only subjects with histologically confirmed advanced disease and no available standard treatment options will be eligible for enrollment. Subjects will undergo screening assessments within 30 days prior to the start of treatment to determine their eligibility for enrollment in the study.
- Conditions
- Cancer
- Being tested
- Dabrafenib, Trametinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabrafenibDrug
Dabrafenib is a 150 mg twice daily capsule administered orally on a continuous basis
TrametinibDrug
Trametinib is a 2 mg once daily tablet administered orally on a continuous basis.
| Study group | Role | What they receive |
|---|---|---|
| Dabrafenib + Trametinib | Experimental | Subjects will receive Dabrafenib 150 mg twice daily orally plus Trametinib 2 mg once daily orally on a continuous basis. A treatment cycle is 28 days in duration. Subjects will continue treatment until an unacceptable toxicity, disease progression, or death occurs. Receives: Drug: Dabrafenib; Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
Disease control Rate (DCR) is defined as the proportion of subjects with objective evidence of complete response (CR), partial response (PR), or stable disease (SD).
Measured: From study treatment start date until first documented complete response, partial response or stable disease, assessed up to 36 months
Secondary outcomes (3)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from first dose until death due to any cause.
Measured: From study treatment start date until date of of death from any cause, assessed up to 36 months
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause.
Measured: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months
Objective Response Rate (ORR)
Overall Response Rate (ORR) is defined as the percentage of participants with a confirmed overall response by investigator assessment as defined by the pre-specified response criteria.
Measured: From study treatment start date until first documented complete response or partial response, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start20 Jun 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Se Jun Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Se Jun Park, Seoul St. Mary's Hospital
- Investigators
- Se Jun Park, MD, PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876806
- Sponsor's protocol ID
- BROAD
- Status last verified
- Nov 2023
- First submitted
- 17 May 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label Study of Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations
- ClinicalTrials.gov ID
- NCT05876806
- Acronym / sponsor ID
- BROAD
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Se Jun ParkUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 May 2023 (actual)
- 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 is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with solid tumors with BRAF V600E mutation or clinically actionable BRAF gene alterations.
Detailed description
Dabrafenib and trametinib combination treatment can offer a therapeutic option for patients with solid cancers harboring specific gene mutations, for whom there are no alternative treatments.
Patients with BRAF V600 mutated advanced solid tumor (excluding BRAF V600E/K mutated malignant melanoma, BRAF V600E mutated non-small cell lung cancer, and BRAF V600E mutated colorectal cancer) or patients with other BRAF gene alterations that are regarded to be druggable by the KOSMOS MTB.
This study is designed to determine the disease control rate (DCR) of oral Dabrafenib in combination with oral Trametinib in subjects with BRAF V600E or clinically actionable BRAF mutated cancers. Only subjects with histologically confirmed advanced disease and no available standard treatment options will be eligible for enrollment. Subjects will undergo screening assessments within 30 days prior to the start of treatment to determine their eligibility for enrollment in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dabrafenib + Trametinib | Experimental | Drug: Dabrafenib, Drug: TrametinibSubjects will receive Dabrafenib 150 mg twice daily orally plus Trametinib 2 mg once daily orally on a continuous basis. A treatment cycle is 28 days in duration. Subjects will continue treatment until an unacceptable toxicity, disease progression, or death occurs. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient who agreed to participate in the KOSMOS-II master observation study
- 19 years of age or older
- Patients with BRAF V600 mutated advanced solid tumor (excluding BRAF V600E/K mutated malignant melanoma, BRAF V600E mutated non-small cell lung cancer, and BRAF V600E mutated colorectal cancer)
- Patients with other BRAF gene alterations that are regarded to be actionable by the KOSMOS MTB
- Disease progression after ≥ 1-prior line of systemic treatment and no standard treatment option
Key exclusion criteria (31 listed)
- Prior treatment with a BRAF inhibitor (including, but not limited to, dabrafenib, vemurafenib, encorafenib) or MEK inhibitor (including, but not limited to, trametinib, binimetinib, selumetinib, cobimetinib) or ERK inhibitor (including, but not limited to, ravoxertinib, ulixertinib, CC-90003, MK-8353)
- History of malignancies with confirmed activating RAS mutation.
- Hypersensitivity to the active ingredients and additives of investigational product.
- Presence of any unresolved ≥Grade 2 (per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) toxicity from previous anti-cancer therapy at the time of enrollment. (Except toxicities which are not clinically significant such as alopecia, skin discoloration, and neuropathy).
- Any anti-cancer treatment (local treatment, chemotherapy, immunotherapy, targeted therapy) within 2 weeks prior to the start of study treatment.
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 is a 150 mg twice daily capsule administered orally on a continuous basis | Drug | Dabrafenib + Trametinib |
| TrametinibTrametinib is a 2 mg once daily tablet administered orally on a continuous basis. | Drug | Dabrafenib + Trametinib |
Primary outcome
Disease Control Rate (DCR)
Time frame: From study treatment start date until first documented complete response, partial response or stable disease, assessed up to 36 months
Disease control Rate (DCR) is defined as the proportion of subjects with objective evidence of complete response (CR), partial response (PR), or stable disease (SD).
3 secondary outcomes
Overall Survival (OS)
Time frame: From study treatment start date until date of of death from any cause, assessed up to 36 months
Progression Free Survival (PFS)
Time frame: From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months
Objective Response Rate (ORR)
Time frame: From study treatment start date until first documented complete response or partial response, assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
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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.
Se Jun Park, MD, PhD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dabrafenib and Trametinib in people with Cancer, run by Se Jun Park at 1 site in South Korea.
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 12 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Se Jun Park, MD, PhD (82-2-2258-6757, psj6936@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (DCR) (time frame: From study treatment start date until first documented complete response, partial response or stable disease, assessed up to 36 months). 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 30 Nov 2023.