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New treatment option for Advanced Solid Tumors
Official title Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT04222413
What this study is testing
What is Metarrestin?
Metarrestin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for advanced solid tumors.
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
- Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths.
- 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 12 to 120
You may be able to join if
- Adult (\>= 18 years) people with:
- histologically or cytologically confirmed solid tumors (Phase IA). OR --histologically or cytologically confirmed pancreatic, colorectal, or breast...
- Pediatric (\>=12 and \< 18 years) people with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including...
- people must have disease that:
- is not amenable to potentially curative resection,
You likely can't join if
- Anticancer treatment within designated period before treatment initiation including:
- minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests...
- major surgical procedure or curative radiation treatment within 28 days;
- palliative radiation treatment within 14 days;
- chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;
- experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;
See the full eligibility criteria
Who can join
- Adult (\>= 18 years) people with:
- histologically or cytologically confirmed solid tumors (Phase IA). OR --histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB) OR
- Pediatric (\>=12 and \< 18 years) people with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell/sclerosing and pleomorphic subtypes of...
- people must have disease that:
- is not amenable to potentially curative resection,
- spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor
- has site measurable per RECIST 1.1
- progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)
- have no standard therapy option available (Phase IB2)
- Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.
- Performance status --Karnofsky \>= 70% (for patients \>= 16 years old), Lansky \>= 70% (for patients \<16 years old)
- Adequate hematological function defined by:
- absolute neutrophil count (ANC) \>= 1.0 x 10(9)/L,
- transfusion-independent platelet count \>= 100 x 10(9)/L,
- Hgb \>= 9 g/ dL (patients who have received \<= 2 PRBC transfusions within 48 hours are eligible)
- Adequate coagulation as defined by: --INR\<1.5 (or \< 3.0 if people are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to people who are receiving...
- Adequate hepatic function defined by:
- a total bilirubin level \<= 1.5 x ULN, (total bilirubin \<= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)
- an AST level \<= 3xULN
- an ALT level \<= 3 xULN
- Adequate renal function defined by:
- Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl) ---\ = 45 mL/min/1.73 m\^2 for participant with creatinine levels \>= 1.5 X institutional ULN
- Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.
- The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or...
- Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.
- Weight \>= 35 kg.
- Ability of subject or parent/guardian to understand and the willingness to sign a written informed consent document.
- people must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).
- Ability to swallow oral capsules.
What rules you out
- Anticancer treatment within designated period before treatment initiation including:
- minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or...
- major surgical procedure or curative radiation treatment within 28 days;
- palliative radiation treatment within 14 days;
- chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;
- experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;
- chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and...
- Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong...
- people with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:
- hypertrophic cardiomyopathy
- arrhythmogenic right ventricular cardiomyopathy
- abnormal ejection fraction (echocardiogram [ECHO]) \<= 53% (if a range is given then the upper value of the range will be used)
- previous moderate or severe impairment of left ventricular systolic function (LVEF \<45%)
- severe valvular heart disease
- atrial fibrillation with a ventricular rate \>100 bpm on EKG at rest
- Fridericia's corrected QT interval (QTcF) \>= 480 msec (adults) or \>= 460 msec (pediatric people, aged 12 to \<18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart...
- HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current...
- Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: people with a history of cervical carcinoma in situ, superficial or non-invasive bladder...
- Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.
- people with central nervous system (CNS) metastases or CNS disorders known to increase possible neurotoxicity of metarrestin in case of compromised blood-brain barrier (e.g. recent stroke (\<3 months of treatment...
- Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.
- Patients with a history of any seizures or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or...
- Clinically relevant diseases (for example, inflammatory bowel disease) and / or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate...
- Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery...
- Pregnant individuals.
The study team makes the final eligibility decision.
Where it's taking place
- Fairway, Kansas, United States
- Bethesda, Maryland, 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, 12 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fairway, Kansas, United States; Bethesda, Maryland, 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.