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Topoisomerase I inhibitors

Topotecan + ATR Kinase Inhibitor for Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Anish Thomas, M.D.
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
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Adequate organ functions: Hemoglobin greater than or equal to 9.0 g/dL, Absolute neutrophil count greater than or equal to 1.5x10^9/L, Platelets greater than or equal to 100x10^9/L, Total Bilirubin less than or equal to 2.0 mg/dL, Transaminases less than or equal to 2 x upper limit of normal (ULN) or if liver metastases were present, less than or equal to 3xULN, Creatinine less than or equal to 1.5 mg/dL or creatinine clearance by Cockcroft-Gault formula greater than or equal to 60 mL/min
Must not have
Subjects with symptomatic brain metastases, subjects requiring strong inhibitors or inducers of cytochrome p450, family 3, subfamily A (CYP3A), evidence of severe or uncontrolled systemic disease, or any concurrent condition which could compromise participation in the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on-study date until date of death, an average of 6.95 months.
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of VX-970 (M6620) when given with topotecan and to see how well it works in treating small cell lung cancer.

Who is the study for?
Adults over 18 with small cell lung cancer or related cancers, who've had chemotherapy. They must have a performance status indicating they can care for themselves and do light work, measurable disease by certain criteria, and agree to use contraception. Not eligible if they've had recent chemo, surgery, radiotherapy, or are pregnant.
What is being tested?
The trial is testing the combination of topotecan (a chemotherapy drug) with VX-970 (M6620), which may inhibit cancer cells' DNA repair mechanisms. The study has two parts: finding the safest dose combination and then giving that dose to more participants to assess its effectiveness.
What are the potential side effects?
Participants might experience side effects from both drugs such as fatigue, nausea, hair loss due to topotecan; specific side effects of VX-970 aren't listed but could include reactions at the infusion site or general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of the day.
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My blood and organ tests meet the required levels for treatment.
Select...
I have SCLC, NSCLC, ovarian, cervical, or neuroendocrine cancer and have had at least one chemotherapy.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe brain metastases or conditions that could affect my study participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on-study date until date of death, an average of 6.95 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and on-study date until date of death, an average of 6.95 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Ph I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Topotecan
Ph I: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of VX-970 (M6620)
+1 more
Secondary study objectives
Percentage of Peripheral Blood Mononuclear Cells (PBMCs): Cluster of Differentiation 14 (CD14)+ Monocytes Among Viable Cells, and Regulatory T Cells Among Cluster of Differentiation 4 (CD4)+ T Cells At Baseline and Post-Treatment
Phase I and Phase II: Duration of Response (DOR)
Phase I and Phase II: Overall Survival (OS)
+5 more
Other study objectives
Phase I Number of Participants With a Dose Limiting Toxicity (DLT)

Side effects data

From 2020 Phase 3 trial • 444 Patients • NCT03061812
58%
ANAEMIA
39%
NEUTROPENIA
35%
THROMBOCYTOPENIA
31%
NAUSEA
27%
DECREASED APPETITE
27%
FATIGUE
22%
CONSTIPATION
19%
LEUKOPENIA
19%
DIARRHOEA
19%
DYSPNOEA
16%
ASTHENIA
16%
ALOPECIA
13%
VOMITING
13%
MALIGNANT NEOPLASM PROGRESSION
12%
COUGH
11%
EPISTAXIS
10%
HYPOKALAEMIA
9%
HEADACHE
9%
NEUTROPHIL COUNT DECREASED
9%
BACK PAIN
9%
OEDEMA PERIPHERAL
9%
FEBRILE NEUTROPENIA
9%
ABDOMINAL PAIN
8%
ARTHRALGIA
7%
INSOMNIA
6%
URINARY TRACT INFECTION
5%
PNEUMONIA
5%
PLATELET COUNT DECREASED
5%
WEIGHT DECREASED
5%
MYALGIA
5%
DYSGEUSIA
5%
PARAESTHESIA
5%
PYREXIA
5%
GENERAL PHYSICAL HEALTH DETERIORATION
4%
PLEURAL EFFUSION
3%
CHEST PAIN
3%
HYPOTENSION
2%
NEOPLASM PROGRESSION
2%
HYPOXIA
2%
SEPSIS
2%
HYPONATRAEMIA
2%
PERICARDIAL EFFUSION
2%
HYPOALBUMINAEMIA
2%
ASPARTATE AMINOTRANSFERASE INCREASED
2%
INFLUENZA
2%
PANCYTOPENIA
2%
CONFUSIONAL STATE
1%
BRONCHITIS
1%
CHOLANGITIS
1%
GENERAL PHYSICAL CONDITION ABNORMAL
1%
PNEUMOTHORAX
1%
ALANINE AMINOTRANSFERASE INCREASED
1%
ORCHITIS
1%
CANDIDA INFECTION
1%
DISEASE PROGRESSION
1%
BONE PAIN
1%
SUPERIOR VENA CAVA SYNDROME
1%
CERVICAL CORD COMPRESSION
1%
LUNG ABSCESS
1%
MUSCULAR WEAKNESS
1%
VERTIGO
1%
HEPATIC FAILURE
1%
GASTROENTERITIS
1%
FALL
1%
SMALL CELL LUNG CANCER
1%
HYPERGLYCAEMIA
1%
EMBOLIC STROKE
1%
TUMOUR PAIN
1%
NEUTROPENIC SEPSIS
1%
MEMORY IMPAIRMENT
1%
RENAL FAILURE
1%
STAPHYLOCOCCAL INFECTION
1%
PNEUMONIA ASPIRATION
1%
RESPIRATORY FAILURE
1%
HAEMATOTOXICITY
1%
INTRACRANIAL PRESSURE INCREASED
1%
ACUTE MYOCARDIAL INFARCTION
1%
ANGINA UNSTABLE
1%
APLASIA
1%
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
1%
GASTROINTESTINAL HAEMORRHAGE
1%
NON-CARDIAC CHEST PAIN
1%
CANCER PAIN
1%
LUNG NEOPLASM
1%
LUNG NEOPLASM MALIGNANT
1%
MALIGNANT NEOPLASM OF SPINAL CORD
1%
NERVOUS SYSTEM DISORDER
1%
SYNCOPE
1%
MENTAL STATUS CHANGES
1%
RASH
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topotecan
Rovalpituzumab Tesirine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Phase II VX-970 (M6620) + topotecanExperimental Treatment2 Interventions
VX-970 (M6620) + topotecan at maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D)
Group II: 1/Phase I VX-970 (M6620) + topotecanExperimental Treatment2 Interventions
VX-970 (M6620) + topotecan at escalating doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
2017
Completed Phase 3
~2460

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,017,939 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
854 Total Patients Enrolled

Media Library

Topotecan (Topoisomerase I inhibitors) Clinical Trial Eligibility Overview. Trial Name: NCT02487095 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: 1/Phase I VX-970 (M6620) + topotecan, 2/Phase II VX-970 (M6620) + topotecan
Non-Small Cell Lung Cancer Clinical Trial 2023: Topotecan Highlights & Side Effects. Trial Name: NCT02487095 — Phase 1 & 2
Topotecan (Topoisomerase I inhibitors) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02487095 — Phase 1 & 2
~6 spots leftby Nov 2025
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