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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 up to 6 months after completion of study treatment
Awards & highlights

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up 6 months after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up 6 months after completion of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Recommended phase 2 dose (RP2D) of ATR kinase inhibitor M6620 (VX-970, berzosertib) and irinotecan hydrochloride
Secondary outcome measures
Incidence of adverse events of M6620 (VX-970, berzosertib) and irinotecan hydrochloride
Incidence of stable disease
Overall response rate
+3 more
Other outcome measures
Change in biomarker levels

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 2
~1720
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Computed Tomography
2017
Completed Phase 2
~2720
Berzosertib
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,335 Total Patients Enrolled
Liza C VillaruzPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO
2 Previous Clinical Trials
22 Total Patients Enrolled

Media Library

Berzosertib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02595931 — Phase 1
Small Cell Lung Cancer Research Study Groups: Treatment (irinotecan, M6620)
Small Cell Lung Cancer Clinical Trial 2023: Berzosertib Highlights & Side Effects. Trial Name: NCT02595931 — Phase 1
Berzosertib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02595931 — Phase 1
~7 spots leftby Jul 2025