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

Part of paid clinical trials in Fairway, Kansas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04222413
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Breast Cancer
  • Advanced Solid Tumors
  • Colorectal Neoplasms
  • Malignant Peripheral Nerve Sheath Tumor
  • Metastatic Pancreatic Cancer
  • Pediatric Solid Tumor

Eligibility Criteria

Sex
ALL
Age
12 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Metarrestin — DRUG
    Phase IA: Loading dose on Day 1 of Cycle 1 for Dose Levels 1-7. Loading dose on Days 1 and 3 of Cycle 1 for Dose Levels 8-11. After the loading dose on Day 1 or Days 1 and 3 of Cycle 1, continue on Mondays-Wednesdays-Fridays of every following cycle. Phase IB: PO according to the dose and schedule estimated during Phase IA

Study Details

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 normal activities Participants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary. Participants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body. Adult participants may have tumor biopsies. Participants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends. ...

Key Dates

Start date
Oct 27, 2020
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
116 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Arm 1
    Escalating/de-escalation doses of metarrestin
  • Experimental: 2/Arm 2
    MTD of metarrestin

Primary Outcome Measure

To identify the maximum tolerated dose (MTD) of metarrestin in subjects with metastatic solid tumors [ Time Frame: 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of KansasFairwayKansas66205
Joaquina Baranda, MD
[email protected]
913-588-4709
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

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By research site
University of Kansas· Fairway, KSNational Institutes of Health Clinical Center· Bethesda, MD

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