AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

RecruitingPhase 1Ages 12 Years - 120 YearsAllNational Cancer Institute (NCI)
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs. Objective: To find a safe dose of metarrestin and to see if this dose shrinks tumors. Eligibility: Adults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options. Design: Participants will be screened with: * blood tests * physical exam * documentation of disease confirmation or tumor biopsy * electrocardiogram to evaluate the heart * review of their medicines and their ability to do their norma

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
* INCLUSION CRITERIA: * Adult (\>= 18 years) subjects 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) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell/sclerosing and pleomorphic subtypes of RMS (Phase IB). * Subjects 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 (Phase IB only). * 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 subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT/PE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded * 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)\* ---\< 1.5x institution upper limit of normal OR ---\>= 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 barrier method of birth control; abstinence) prior to study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug. * Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation. * Weight: \>= 35 kg (\>= 18 years old) or \>=40 kg (\>= 12 and \< 18 years old). * Ability of subject or parent/guardian to understand and the willingness to sign a written informed consent document. * Subjects 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. EXCLUSION CRITERIA: * 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 ureteral stenting; * 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 non-classical alkylating agent (dacarbazine, temozolomide) within 28 days. * 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 CYP3A4 inhibiting/inducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation. Note: dihydropyridine calcium - channel blockers are permitted for management of underling disease. * Subjects 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 subjects, aged 12 to \<18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome. * 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 study and possible for adverse pharmacokinetic and/or pharmacodynamic interactions. * Previous malignant di
๐Ÿ’Š

What it tests

  • Metarrestin
๐Ÿ“

Where

2 sites
University of Kansas
Fairway, United States
National Institutes of Health Clinical Center
Bethesda, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy