๐ฌIn 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.
๐ 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.
* Patients receiving medications known to carry a high to moderate risk to lower seizure threshold within 2 weeks prior to treatment initiation.
* 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