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PARP Inhibitor

M6620 + Irinotecan for Cancer

Phase 1

Waitlist Available

Led By Liza C Villaruz

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically confirmed metastatic or unresectable malignancy that is refractory to standard therapy or for which no standard therapy exists and where irinotecan is deemed a reasonable treatment option

Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam

Must not have

HIV-positive patients with poorly controlled disease

Patients with unstable brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to up 6 months after completion of study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of M6620 and irinotecan hydrochloride in treating patients with metastatic solid tumors. M6620 and irinotecan hydrochloride may stop the growth of tumor cells.

Who is the study for?

Adults with metastatic or inoperable solid tumors, including pancreatic, colorectal, and small cell lung cancer. Participants must have certain organ functions within normal limits and a life expectancy over 12 weeks. They should be willing to use contraception and undergo mandatory biopsies if in the expansion cohort.

What is being tested?

The trial is testing M6620 (berzosertib) combined with irinotecan hydrochloride to determine safe dosages and side effects. It targets patients whose tumors may not respond to standard treatments or for whom no standard treatment exists.

What are the potential side effects?

Potential side effects include reactions related to blocking enzymes needed for tumor growth which could affect cell function broadly, possibly leading to digestive issues, blood disorders, fatigue, liver problems, or other organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer cannot be removed by surgery, doesn't respond to standard treatments, and irinotecan is considered a treatment option.

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I have a tumor that can be measured with scans or exams.

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I am 18 years old or older.

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I am fully active or able to carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My HIV is not well-managed.

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I have brain metastases that are not stable.

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I am allergic to medications similar to M6620 or irinotecan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after completion of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after completion of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after completion of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Recommended phase 2 dose (RP2D) of ATR kinase inhibitor M6620 (VX-970, berzosertib) and irinotecan hydrochloride

Secondary study objectives

Incidence of adverse events of M6620 (VX-970, berzosertib) and irinotecan hydrochloride

Incidence of stable disease

Overall response rate

+3 more

Other study objectives

Change in biomarker levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (irinotecan, M6620)Experimental Treatment5 Interventions

Patients receive irinotecan hydrochloride IV over 90 minutes and M6620 IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy and collection of blood samples throughout the study and undergo CT at screening, throughout the study, and during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Irinotecan Hydrochloride

2010

Completed Phase 3

~2050