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New treatment option for Tumor, Solid
Official title Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
ClinicalTrials.gov ID: NCT03454035
What this study is testing
What is Ulixertinib?
Ulixertinib is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for tumor, solid.
Also referred to as BVD-523.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the...
- Age ≥ 18 years at the time of consent (no upper age limit)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Tumor Eligibility:
- Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted...
You likely can't join if
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on the study)
- Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug...
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
- Major surgery within 28 days prior to day -6 of ulixertinib
- Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, oranges, pummelos, and exotic citrus fruits from 7 days prior to day -6 of...
- Intake of any herbal preparations or medications (including, but not limited to, Saint John's Wort and ginkgo biloba) and dietary supplements within...
See the full eligibility criteria
Who can join
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent (no upper age limit)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Tumor Eligibility:
- Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted standard of care
- Expansion cohort (at RP2D): metastatic pancreatic cancer or malign melanoma patients who have received at least one line of therapy in the metastatic setting
- Expansion cohort (at RP2D) for histologically confirmed unresectable stage III or stage IV melanoma with the following additional eligibility requirements:
- Tumors molecular profiling genetic aberrations: NRASG12/G13/Q61, KRASG12/G13, HRASG12/G13, any amplifications of the NRAS, KRAS, or HRAS genes. For NF1 mutations, people with loss-of-function NF1mutations and without...
- Documented disease refractory to at least one PD1/PD-L1 inhibitor, defined as disease progression following at least two infusions of the same drug.
- people with RAS-mutant and NF1-mutant (no concurrent BRAFV600 mutations) melanoma that have not taken prior immune checkpoint inhibitors will be allowed if they are not eligible to receive prior immune checkpoint...
- Measurable or non-measurable (but evaluable) disease according to RECIST v1.1 for dose escalating cohorts; measurable disease as per RECIST v1.1 required for expansion cohort
- Life expectancy ≥ 12 weeks
- Recovered from all reversible acute toxic effects of last anti-cancer treatment (other than alopecia) to ≤Grade 1 or baseline. Patients with baseline neuropathy that is ≤ grade 2 are eligible for enrollment.
- Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to day -6 of ulixertinib Hemoglobin (Hgb) ≥ 9 g/dL Absolute Neutrophil Count (ANC) ≥ 1,500 /mm3...
- Adequate cardiac function; left ventricular ejection fraction (LVEF) \>50% as assessed by ultrasound/echocardiography (ECHO); corrected QT interval (QTc) \<470ms
- Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to day -6 of ulixertinib. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have...
- Females of childbearing potential and males must be willing to abstain from heterosexual activity\ or use effective methods of contraception from the time of informed consent until 120 days after treatment...
- Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Willing to provide archival tissue (if available) and consent to mandatory pretreatment and on-treatment biopsy as deemed safe by the treating physician (expansion cohort only) for research purposes only.
What rules you out
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on the study)
- Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to day -6 of...
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
- Major surgery within 28 days prior to day -6 of ulixertinib
- Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, oranges, pummelos, and exotic citrus fruits from 7 days prior to day -6 of ulixertinib and during the entire study due to potential CYP3A4...
- Intake of any herbal preparations or medications (including, but not limited to, Saint John's Wort and ginkgo biloba) and dietary supplements within 7 days prior to day -6 of ulixertinib due to potential CYP3A4...
- Unable or unwilling to discontinue use of any drug known to be a strong inhibitor of CYP3A4, CYP1A2 or CYP2D6 or strong inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to...
- Unable or unwilling to discontinue use of any drug known to be a sensitive CYP3A4 substrate with a narrow therapeutic index as defined in the protocol.
- Central nervous system metastases are allowed only for patients RAS-mutated and NF1-mutant melanoma cohorts (1) no leptomeningeal disease is present, (2) Intracranial disease is controlled by prior therapies, as...
- Any important medical illness or abnormal laboratory finding that would increase the risk of participating in the study (based on the investigator's judgment)
- Psychiatric illness/social situations that would limit compliance with study requirements
- Has a known additional malignancy that is active and/or progressive requiring treatment; non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix, prior history of prostate cancer...
- Impaired GI function or GI disease that may significantly impair absorption (e.g., inflammatory bowel disease (IBD), malabsorption syndrome, small bowel resection, uncontrolled vomiting or diarrhea)
- Inability to swallow oral medications
- Patients with autoimmune diseases that require systemic corticosteroid treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.