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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on-study date until date of death, an average of 6.95 months.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself and am up and about more than half of the day.
Select...
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.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on-study date until date of death, an average of 6.95 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on-study date until date of death, an average of 6.95 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreOther outcome measures
Phase I Number of Participants With a Dose Limiting Toxicity (DLT)
Side effects data
From 2020 Phase 3 trial • 444 Patients • NCT0306181258%
ANAEMIA
39%
NEUTROPENIA
35%
THROMBOCYTOPENIA
31%
NAUSEA
27%
FATIGUE
27%
DECREASED APPETITE
22%
CONSTIPATION
19%
DYSPNOEA
19%
LEUKOPENIA
19%
DIARRHOEA
16%
ALOPECIA
16%
ASTHENIA
13%
VOMITING
13%
MALIGNANT NEOPLASM PROGRESSION
12%
COUGH
11%
EPISTAXIS
10%
HYPOKALAEMIA
9%
NEUTROPHIL COUNT DECREASED
9%
BACK PAIN
9%
OEDEMA PERIPHERAL
9%
FEBRILE NEUTROPENIA
9%
ABDOMINAL PAIN
9%
HEADACHE
8%
ARTHRALGIA
7%
INSOMNIA
6%
URINARY TRACT INFECTION
5%
PARAESTHESIA
5%
PLATELET COUNT DECREASED
5%
DYSGEUSIA
5%
WEIGHT DECREASED
5%
PYREXIA
5%
MYALGIA
5%
PNEUMONIA
5%
GENERAL PHYSICAL HEALTH DETERIORATION
4%
PLEURAL EFFUSION
3%
HYPOTENSION
3%
CHEST PAIN
2%
INFLUENZA
2%
HYPOXIA
2%
HYPOALBUMINAEMIA
2%
ASPARTATE AMINOTRANSFERASE INCREASED
2%
PANCYTOPENIA
2%
HYPONATRAEMIA
2%
CONFUSIONAL STATE
2%
SEPSIS
2%
NEOPLASM PROGRESSION
2%
PERICARDIAL EFFUSION
1%
MUSCULAR WEAKNESS
1%
RENAL FAILURE
1%
RASH
1%
VERTIGO
1%
SMALL CELL LUNG CANCER
1%
CERVICAL CORD COMPRESSION
1%
NEUTROPENIC SEPSIS
1%
ORCHITIS
1%
CANDIDA INFECTION
1%
HEPATIC FAILURE
1%
HAEMATOTOXICITY
1%
LUNG NEOPLASM MALIGNANT
1%
TUMOUR PAIN
1%
PNEUMOTHORAX
1%
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
1%
BRONCHITIS
1%
LUNG ABSCESS
1%
ALANINE AMINOTRANSFERASE INCREASED
1%
GASTROENTERITIS
1%
CHOLANGITIS
1%
HYPERGLYCAEMIA
1%
ACUTE MYOCARDIAL INFARCTION
1%
CANCER PAIN
1%
MEMORY IMPAIRMENT
1%
NERVOUS SYSTEM DISORDER
1%
SYNCOPE
1%
ANGINA UNSTABLE
1%
LUNG NEOPLASM
1%
APLASIA
1%
GASTROINTESTINAL HAEMORRHAGE
1%
STAPHYLOCOCCAL INFECTION
1%
FALL
1%
GENERAL PHYSICAL CONDITION ABNORMAL
1%
BONE PAIN
1%
MALIGNANT NEOPLASM OF SPINAL CORD
1%
INTRACRANIAL PRESSURE INCREASED
1%
MENTAL STATUS CHANGES
1%
PNEUMONIA ASPIRATION
1%
RESPIRATORY FAILURE
1%
SUPERIOR VENA CAVA SYNDROME
1%
DISEASE PROGRESSION
1%
EMBOLIC STROKE
1%
NON-CARDIAC CHEST PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topotecan
Rovalpituzumab Tesirine
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
~2400
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,680 Previous Clinical Trials
40,928,457 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
750 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor can potentially be cured with treatment.I can take care of myself and am up and about more than half of the day.I haven't had chemotherapy, major surgery in the last 4 weeks, or radiotherapy in the last 24 hours.My blood and organ tests meet the required levels for treatment.I do not have severe brain metastases or conditions that could affect my study participation.My cancer can be measured by standard criteria.My cancer is confirmed as small cell lung cancer or related and may or may not respond to platinum-based treatment.I have SCLC, NSCLC, ovarian, cervical, or neuroendocrine cancer and have had at least one chemotherapy.I am 18 years old or older.You have HIV and are taking multiple medications for it, you are pregnant, or you are breastfeeding.I agree to use contraception during and for 6 months after the study, and I am not pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Phase I VX-970 (M6620) + topotecan
- Group 2: 2/Phase II VX-970 (M6620) + topotecan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the past research on Topotecan's effectiveness?
"As of right now, there are 74 clinical trials underway that are studying Topotecan. Out of these, 17 are in Phase 3. Most of the research being conducted for Topotecan is happening in Scottsdale, Arizona; however, there are 3407 locations worldwide where studies involving Topotecan are taking place."
Answered by AI
How many participants are in this clinical trial?
"This particular clinical trial is no longer looking for new participants. The study was originally posted on July 30th, 2015 and the most recent update was on March 17th, 2022. With that said, there are currently 6963 different trials involving patients with uterine cervical neoplasms and 74 trials testing Topotecan that actively recruiting patients."
Answered by AI
What are the main conditions that Topotecan is used to treat?
"Topotecan is a medication that oncologists often prescribe to patients with ovarian cancer. Additionally, this drug can be used to treat leukemia, myelocytic sarcoma, and other malignant neoplasms."
Answered by AI
Are there any patients still needed for this clinical trial?
"Currently, this clinical trial is not accepting any new patients. Although, it's worth noting that this study was originally posted on 7/30/2015 and was last edited on 3/17/2022. If you're interested in other studies, 6963 different trials for uterine cervical neoplasms are actively recruiting participants and 74 trials involving Topotecan are searching for patients."
Answered by AI
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