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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after completion of study treatment

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 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

Irinotecan Hydrochloride

2010

Completed Phase 3

~1940

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1730

Berzosertib

2021

Completed Phase 2

~80

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,087 Total Patients Enrolled

Liza C VillaruzPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO

1 Previous Clinical Trials

106 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what medical condition is Irinotecan Hydrochloride typically utilized?

"Irinotecan Hydrochloride has been clinically approved to treat malignant neoplasms in the pancreas. Additionally, it can be employed for neoplasm metastasis, gastric cancerous tumours and rhabdomyosarcoma cases."

Answered by AI

How many healthcare facilities are participating in this experiment?

"The current clinical trial is running out of Brigham and Women's Hospital located in Nashville, Tennessee; Vanderbilt Breast Center at One Hundred Oaks situated in Sacramento, California; University of California Davis Comprehensive Cancer Center based in Pittsburgh, Pennsylvania as well other 13 different sites."

Answered by AI

Is Irinotecan Hydrochloride a secure option for treating patients?

"Due to minimal evidence of Irinotecan Hydrochloride's safety and efficacy, our team at Power assigned this drug a score of 1."

Answered by AI

What is the participant count for this clinical experiment?

"Affirmative. The clinical trial is open for participants, with the most recent update posted on November 15th 2022. 66 individuals are being accomodated from 13 different medical centres and the study was initially posted in June 8th 2016 according to information available at clinicaltrials.gov"

Answered by AI

Are there any precedent clinical tests involving Irinotecan Hydrochloride?

"At present, there are 276 trials involving Irinotecan Hydrochloride; of which 53 have reached Phase 3. Most studies for this medication are located in Woolloongabba, Queensland but it is also being tested at 885 other sites across the world."

Answered by AI

Are there still spots available within this research endeavor?

"From its inception on the 8th of June 2016 to the present day, this clinical trial has been actively seeking participants. The latest updates were issued on 15 November 2022."

Answered by AI

What are the key objectives being sought after by this clinical investigation?

"The aim of this 28 day trial is to determine the Maximum Tolerated Dose (MTD). Secondary outcomes include monitoring Adverse Events for M6620 and Irinotecan Hydrochloride, examining Pharmacodynamic Parameters related to both medications, as well as tracking Stable Disease incidence. All toxicities will be graded according to Common Terminology Criteria Version 5.0 while Gamma H2AX induction in PBMCs and tumors will also be monitored."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

2016. "M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02595931.

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