98 Participants Needed

Metarrestin for Advanced Cancer

Recruiting at 1 trial location
MH
UR
Overseen ByUdo Rudloff, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to stop taking medications that are moderate or strong inhibitors or inducers of CYP3A4 enzymes before starting the treatment. If you are on such medications, you will need to stop them within a specific time frame based on their half-lives. However, dihydropyridine calcium-channel blockers are allowed.

What makes the drug Metarrestin unique for treating advanced cancer?

Metarrestin is a novel drug that targets a specific protein involved in cancer cell metastasis (spread), which is different from traditional chemotherapy drugs that mainly target rapidly dividing cells. This unique mechanism may offer a new approach for treating advanced cancers that are resistant to other treatments.12345

Research Team

UR

Udo Rudloff, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Adults and children (12-17) with metastatic solid tumors like pancreatic, breast, or colorectal cancer that standard treatments haven't cured. Participants must be over 35 kg in weight, have a certain level of physical ability, and their major organs need to function well. Women who can become pregnant and men must use birth control during the trial.

Inclusion Criteria

I have been diagnosed with pancreatic, colorectal, or breast cancer.
I am mostly able to care for myself and carry on normal activities.
Adequate hematological function defined by ANC >=1.0 (SqrRoot) 10(9)/L, transfusion-independent platelet count >=100 (SqrRoot) 10(9)/L, Hgb >=9 g/dL
See 12 more

Exclusion Criteria

I have had cancer other than the one currently being treated.
I haven't had cancer treatment recently.
I was diagnosed with cardiomyopathy less than 6 months ago.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive metarrestin orally in cycles of 28 days until progression or unacceptable toxicity

28 days per cycle
Weekly or every other week visits during the first month, then regular visits

Follow-up

Participants have a follow-up visit 30 days after treatment ends, then follow-up phone calls or emails every 6 months

30 days after treatment, then every 6 months
1 visit (in-person), then remote follow-ups

Dose Escalation

Phase IA to determine the maximum tolerated dose (MTD) of metarrestin

28 days

Dose Expansion

Phase IB to determine the Objective Response Rate (ORR) at the MTD

Every 2 months

Treatment Details

Interventions

  • Metarrestin
Trial OverviewThe trial is testing Metarrestin's safety and effectiveness at shrinking tumors in patients with metastatic cancers. Patients will take Metarrestin orally for as long as they can tolerate it while undergoing regular health checks including blood tests, heart exams, brain activity assessments, imaging scans like CT or MRI, and possibly tumor biopsies.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 2/Arm 2Experimental Treatment1 Intervention
MTD of metarrestin
Group II: 1/Arm 1Experimental Treatment1 Intervention
Escalating/de-escalation doses of metarrestin

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 60 advanced breast cancer patients who had previously been treated with anthracyclines, the combination of vinorelbine and mitomycin C resulted in a 40% overall response rate, with 3 complete and 21 partial responses.
The treatment was generally well tolerated, with myelosuppression being the main side effect, but it was mostly mild to moderate, indicating that this combination could be a viable option for patients with limited treatment alternatives.
Vinorelbine and mitomycin C in anthracycline-pretreated patients with advanced breast cancer.Vici, P., Di Lauro, L., Carpano, S., et al.[2018]
In a randomized phase II study involving 101 patients with locally advanced and locally recurrent breast carcinoma, three new cisplatin-containing chemotherapy combinations showed high rates of complete response (CR) and partial response (PR), with CR rates of 7% for locally advanced and 43% for locally recurrent disease.
The study demonstrated a pathologic complete response (pCR) rate of 12% in locally advanced disease, indicating that these innovative regimens are effective and warrant further testing in phase III trials, despite some severe but generally tolerable toxicities.
Three new active cisplatin-containing combinations in the neoadjuvant treatment of locally advanced and locally recurrent breast carcinoma: a randomized phase II trial.Cocconi, G., Bisagni, G., Ceci, G., et al.[2019]
Recent advancements in the treatment of disseminated non-small-cell lung cancer have introduced newer agents like vinorelbine and paclitaxel, which, when combined with cisplatin, can modestly improve patient survival.
Patients receiving these newer regimens experience a median survival increase of 10 to 15 weeks and a 10% to 15% improvement in 1-year survival rates compared to older treatment combinations.
Recent advances with chemotherapy for NSCLC: the ECOG experience. Eastern Cooperative Oncology Group.Johnson, DH., Chang, AY., Ettinger, DS., et al.[2015]

References

Vinorelbine and mitomycin C in anthracycline-pretreated patients with advanced breast cancer. [2018]
Three new active cisplatin-containing combinations in the neoadjuvant treatment of locally advanced and locally recurrent breast carcinoma: a randomized phase II trial. [2019]
Recent advances with chemotherapy for NSCLC: the ECOG experience. Eastern Cooperative Oncology Group. [2015]
First-line vinorelbine-mitoxantrone combination in metastatic breast cancer patients relapsing after an adjuvant anthracycline regimen: results of a phase II study. [2018]
Doxorubicin-cisplatin-vinblastine combination chemotherapy of advanced endometrial carcinoma: a Southwest Oncology Group Study. [2019]