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PARP Inhibitor
Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
Phase 2
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first administration of study treatment up to 27.7 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called Berzosertib combined with an existing chemotherapy drug, Topotecan. It targets patients with a type of lung cancer that has come back and does not respond to standard treatments. Berzosertib makes the cancer cells weaker by stopping them from repairing themselves, and Topotecan attacks the cancer cells directly.
Eligible Conditions
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from first administration of study treatment up to 27.7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first administration of study treatment up to 27.7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Main Part: Objective Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Independent Review Committee (IRC)
Safety Run-in Part: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)
Safety Run-in Part: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings
+3 moreSecondary study objectives
Main Part: Change From Baseline in Health State as Measured by Visual Analogue Scale (VAS) Component of European Quality of Life 5-dimensions 5 Level Scale (EQ-5D-5L)
Main Part: Change From Baseline in Physical Functioning Measured by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Main Part: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Independent Review Committee (IRC)
+32 moreSide effects data
From 2023 Phase 2 trial • 76 Patients • NCT0476829666%
Anaemia
36%
Thrombocytopenia
32%
Neutropenia
30%
Platelet count decreased
27%
Nausea
25%
Decreased appetite
25%
Asthenia
18%
White blood cell count decreased
18%
Constipation
16%
Neutrophil count decreased
15%
Dyspnoea
15%
Diarrhoea
14%
Vomiting
14%
Fatigue
12%
Lymphocyte count decreased
11%
Hypokalaemia
11%
Pneumonia
10%
Hypoalbuminaemia
10%
Headache
10%
Alanine aminotransferase increased
10%
Aspartate aminotransferase increased
10%
Cough
8%
Weight decreased
8%
Epistaxis
8%
Blood alkaline phosphatase increased
8%
Lipase increased
8%
Hypocalcaemia
7%
Hyponatraemia
7%
Pyrexia
7%
Insomnia
7%
Dizziness
5%
Haemoptysis
5%
Malaise
5%
Mucosal inflammation
5%
Hypomagnesaemia
5%
Gamma-glutamyltransferase increased
5%
Hyperglycaemia
5%
Febrile neutropenia
5%
COVID-19
5%
Hypertension
4%
Gastrooesophageal reflux disease
4%
Liver injury
4%
Oedema peripheral
4%
Dyspnoea exertional
4%
Alopecia
4%
COVID-19 pneumonia
4%
Tachycardia
4%
Abdominal pain
4%
Blood creatinine increased
4%
Hypophosphataemia
4%
Dysgeusia
3%
Haemoglobin decreased
3%
Productive cough
3%
Blood bilirubin increased
3%
Pleural effusion
3%
Localised oedema
3%
Night sweats
3%
Blood magnesium decreased
3%
Neuropathy peripheral
3%
Pruritus
3%
Chest discomfort
3%
Paraesthesia
3%
Pain
3%
Anxiety
3%
Sepsis
3%
Leukopenia
3%
Atrial fibrillation
3%
Abdominal pain upper
3%
Chills
3%
Upper respiratory tract infection
3%
Activated partial thromboplastin time prolonged
3%
Amylase increased
3%
Blood albumin decreased
3%
Blood lactate dehydrogenase increased
3%
Arthralgia
3%
Back pain
3%
Muscle spasms
3%
Dysphonia
3%
Hypotension
3%
Pallor
1%
Metastases to central nervous system
1%
Photosensitivity reaction
1%
Creatinine renal clearance decreased
1%
Acute kidney injury
1%
Electrolyte imbalance
1%
Hepatic pain
1%
Decubitus ulcer
1%
Memory impairment
1%
Pleuritic pain
1%
Blood sodium decreased
1%
Tremor
1%
Gout
1%
Presyncope
1%
Seizure
1%
Pneumonia bacterial
1%
Blood urea increased
1%
Hemiparesis
1%
Device malfunction
1%
Skin lesion
1%
Hypoglycaemia
1%
Lip dry
1%
Herpes zoster reactivation
1%
Cholestasis
1%
Wound infection
1%
Influenza like illness
1%
Conjunctival pallor
1%
Diplopia
1%
Haemorrhoids
1%
Generalised oedema
1%
Injection site pruritus
1%
Electrocardiogram QT prolonged
1%
Rash
1%
Blood phosphorus decreased
1%
C-reactive protein increased
1%
CD4/CD8 ratio decreased
1%
Hypochloraemia
1%
Depression
1%
Dyspnoea paroxysmal nocturnal
1%
Rash pruritic
1%
Secretion discharge
1%
Hyperthermia
1%
Choluria
1%
Swelling face
1%
Hyperbilirubinaemia
1%
Respiratory tract infection
1%
Nail disorder
1%
Haemorrhoids thrombosed
1%
Hyperkalaemia
1%
Transient aphasia
1%
Sinusitis
1%
Confusional state
1%
Pneumonia pneumococcal
1%
Eye discharge
1%
Gingival pain
1%
Sputum discoloured
1%
Oral disorder
1%
Wheezing
1%
Hypoxia
1%
Pneumothorax
1%
Lower gastrointestinal haemorrhage
1%
Pulmonary embolism
1%
Petechiae
1%
Tooth loss
1%
Spinal compression fracture
1%
Cancer pain
1%
Hemianopia homonymous
1%
Nasal congestion
1%
Myelosuppression
1%
Acute coronary syndrome
1%
Vestibular disorder
1%
Disease progression
1%
General physical health deterioration
1%
Multiple organ dysfunction syndrome
1%
Enterococcal sepsis
1%
Lung abscess
1%
Septic shock
1%
Serratia sepsis
1%
Staphylococcal sepsis
1%
Urinary tract infection
1%
Urosepsis
1%
Acute respiratory distress syndrome
1%
Respiratory failure
1%
Coagulopathy
1%
Thrombocytosis
1%
Arrhythmia
1%
Cardiac failure
1%
Sinus tachycardia
1%
Hypothyroidism
1%
Immune-mediated hypothyroidism
1%
Macular oedema
1%
Abdominal discomfort
1%
Abdominal distension
1%
Dry mouth
1%
Dyspepsia
1%
Dysphagia
1%
Flatulence
1%
Chest pain
1%
Face oedema
1%
Gait disturbance
1%
Hypersensitivity
1%
Bronchiolitis
1%
Bronchitis
1%
Candida infection
1%
Diverticulitis
1%
Gastroenteritis
1%
Compression fracture
1%
Fall
1%
Radiation oesophagitis
1%
Radiation pneumonitis
1%
Spinal fracture
1%
Aspartate aminotransferase decreased
1%
Blood cholesterol increased
1%
Blood glucose increased
1%
Blood lactic acid increased
1%
Platelet count increased
1%
Urine output decreased
1%
Malnutrition
1%
Muscular weakness
1%
Pain in extremity
1%
Tumour pain
1%
Disturbance in attention
1%
Nephrolithiasis
1%
Renal impairment
1%
Aphonia
1%
Deep vein thrombosis
1%
Orthostatic hypotension
1%
Phlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety run-in Part (DL2) + Main Part: Berzosertib 210 mg/m^2 + Topotecan 1.25 mg/m^2
Safety run-in Part (Dose Level 1 [DL 1]): Berzosertib 105 mg/m^2 + Topotecan 1.25 mg/m^2
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: Safety run-in Part (Dose Level1 [DL 1]): Berzosertib 105 mg/m^2 + Topotecan 1.25 mg/m^2Experimental Treatment2 Interventions
Participants received Berzosertib at a dose of 105 milligrams per square meter (mg/m\^2 ) intravenously on Day 2 and Day 5 of each 21-daycycle in combination with Topotecan at a dose of 1.25mg/m\^2 intravenously on Days1 through 5 of each 21-day cycle in DL1 of safety run-in part until disease progression or other criteria for study intervention discontinuation are met.
Group II: Safety run-in Part (DL2) +Main Part: Berzosertib 210 mg/m^2 + Topotecan 1.25 mg/m^2Experimental Treatment2 Interventions
Participants received Berzosertib at a dose of 210 mg/m\^2 intravenously on Day 2 and Day 5 of each 21-day cycle in combination with Topotecan at a dose of 1.25 mg/m\^2 intravenously on Days 1 through 5 of each 21-day cycle in DL 1 and DL 2 of safety run-in part and main part until disease progression or other criteria for study intervention discontinuation are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
2017
Completed Phase 3
~2890
Berzosertib
2021
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
446 Previous Clinical Trials
114,826 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
85 Previous Clinical Trials
22,657 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
300 Previous Clinical Trials
61,103 Total Patients Enrolled