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ATR Kinase Inhibitor

Topotecan Hydrochloride for Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Anish Thomas

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

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Patients enrolled to the primary cohort must have limited- or extensive-disease SCLC at diagnosis, with relapse at study entry with measurable disease at random assignment per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Both platinum-sensitive and platinum-resistant patients will be included

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests if a combo of M6620+topotecan can better shrink small cell lung/extrapulmonary cancer than topotecan alone.

Who is the study for?

Adults with relapsed small cell lung cancer or small cell cancers from other body parts, who have measurable disease and are in good physical condition. They must not be pregnant, agree to contraception, and can't have untreated brain metastases or severe illnesses that could interfere with the trial.Check my eligibility

What is being tested?

The trial is testing if adding berzosertib (M6620) to topotecan chemotherapy is more effective for patients whose small cell lung cancer has returned compared to topotecan alone. Berzosertib may block enzymes that help cancer cells repair damaged DNA.See study design

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues like fatigue, nausea, low blood counts leading to increased infection risk, hair loss, and possible organ damage due to the new drug's effect on DNA repair.

Eligibility Criteria

Inclusion Criteria

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

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My hepatitis B virus is under control with treatment.

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My small cell lung cancer has returned and can be measured.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Objective response rate (ORR)

Overall survival (OS)

Side effects data

From 2013 Phase 3 trial • 4312 Patients • NCT00011986

97%

Neutropenia

94%

Leukopenia

80%

Anemia

76%

Thrombocytopenia

47%

Gastrointestinal

43%

Constitutional

38%

Other Hemotologic

34%

Pain

17%

Infection/Fever

17%

Peripheral neurologic

17%

Pulmonary

14%

Neurologic

11%

Metabolic

10%

2nd Primary

Hepatic

Dermatologic

Cardiovascular

Allergy

Hemorrhage

Genitourinary/Renal

Musculoskeletal

Ocular/Visual

Endocrine

Auditory

Thrombosis/Embolism

Ileus

Infection Documented W Grd 3/4 Neutropn.

Infection Without Neutropenia

Coagulation

Sexual

Platelets

Allergic Reaction/Hypersensitivity

Febrile Neutropenia-Fuo Infect Not Docum

100%

80%

60%

40%

20%

Study treatment Arm

Carbo/Gemcitabine - Carbo/Taxol

Carbo/Taxol/Gemcitabine

Carbo/Taxol/Doxil

Carbo/Topotecan - Carbo/Taxol

Carbo/Taxol

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (topotecan hydrochloride, M6620)Experimental Treatment5 Interventions

Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and M6620 IV over 60 minutes on days 2 and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan during screening and on study as well as a tumor biopsy during screening. Patients may also undergo blood sample collection during screening and on study.

Group II: Arm I (topotecan hydrochloride )Active Control4 Interventions

Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II at disease progression. Patients undergo a CT scan during screening and on study as well as a tumor biopsy during screening. Patients may also undergo blood sample collection during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Berzosertib

2021

Completed Phase 2

~80

Biopsy

2014

Completed Phase 4

~850

Computed Tomography

2017

Completed Phase 2

~2720

Topotecan Hydrochloride

2013

Completed Phase 3

~6120

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,072 Total Patients Enrolled

Anish ThomasPrincipal InvestigatorNational Cancer Institute LAO

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

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

How have safety assessments for Topotecan Hydrochloride been evaluated?

"Drawing from clinical evidence, we can safely say that Topotecan Hydrochloride is relatively secure and thus merits a score of 2 on our safety scale. This drug has successfully passed Phase 2 trials but efficacy data remains inconclusive."

Answered by AI

Could you provide an overview of the existing research regarding Topotecan Hydrochloride?

"Topotecan Hydrochloride was first investigated in 2005 at St. Jude Children's Research Hospital and has since seen a total of 226 completed studies, 69 of which are still active, predominantly located in Wilkesboro, Kansas."

Answered by AI

What conditions typically respond to treatment with Topotecan Hydrochloride?

"Topotecan Hydrochloride is a medication often prescribed to treat ovarian cancer. It can also be utilized as an effective remedy for acute myeloid leukemia, sarcoma, and other malignant neoplasms."

Answered by AI

What is the geographic scope of this research experiment?

"At the moment, 32 medical centres are recruiting for this clinical trial. Examples of cities included in these sites include Wilkesboro, Salina and Bethesda. If you plan to participate it is recommended that you choose a location nearest to your residence in order to reduce transportation costs associated with the study."

Answered by AI

Is this trial actively looking for participants now?

"At this moment, no new participants are being accepted for the clinical trial. The study was first published on August 23rd 2019 and underwent its latest update on February 18th 2023. If you're searching for other medical trials, 2734 studies enrolling patients with extensive stage small cell lung cancer and 69 Topotecan Hydrochloride related investigations are actively recruiting volunteers."

Answered by AI

What is the upper limit of participants taking part in this investigation?

"This trial is currently not accepting applicants. It was first published on August 23, 2019 and last edited February 18, 2023. If you are looking for other medical trials to join, there are 2734 different studies with extensive stage small cell lung cancer and 69 separate trials involving topotecan hydrochloride now actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs

2019. "Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03896503.

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