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PARP Inhibitor
IMP4297 + Temozolomide for Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Impact Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
In Part I: The patient must have histologically or cytologically confirmed advanced solid tumor that is refractory to standard treatment or for which no standard treatment exists, including but not limited to triple-negative breast cancer (TNBC), SCLC, ovarian cancer (OC) and metastatic castration-resistant prostate cancer (mCRPC)
In Part I: Patients have an ECOG performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the initiation of study drugs until the end of dose escalation phase(approximately 1 year)
Awards & highlights
Study Summary
This trial looks at a new cancer treatment for advanced solid tumors and ES-SCLC, focusing on safety, tolerability and effectiveness.
Who is the study for?
Adults with advanced solid tumors or small cell lung cancer (SCLC) that's worsened after first-line platinum-based therapy can join. They must be in good physical condition, have a life expectancy of at least 12 weeks, and adequate organ function. Women must not be pregnant or breastfeeding and use birth control; men agree to contraception too. Exclusions include known drug allergies, recent other treatments, CNS primary tumors or uncontrolled metastases, certain heart conditions, inability to swallow pills, active infections like HIV/hepatitis B/C.Check my eligibility
What is being tested?
The trial is testing the combination of a PARP inhibitor called IMP4297 with temozolomide chemotherapy to see how safe it is and if it works against advanced solid tumors and SCLC that has progressed after initial treatment. It's an open-label study where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Possible side effects may include nausea, fatigue, blood disorders like anemia or low platelets which could lead to bleeding issues or increased infection risk due to low white blood cells. There might also be allergic reactions related to the drugs used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an advanced cancer that doesn't respond to standard treatments.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the initiation of study drugs until the end of dose escalation phase(approximately 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the initiation of study drugs until the end of dose escalation phase(approximately 1 year)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part I: Dose Escalation MTD
Part I: Dose Escalation RP2D
Part I: Dose Escalation safety and tolerability
+1 moreSecondary outcome measures
Part I: Dose Escalation anti-tumor activity
Part I: Dose Escalation plasma PK profile of IMP4297 and temozolomide
Part I: Dose Escalation,effect of IMP4297 on QT interval
+4 moreSide effects data
From 2016 Phase 2 trial • 175 Patients • NCT0105531436%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Aspartate aminotransferase increased
9%
Anemia
9%
Mucositis oral
9%
Vomiting
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Anxiety
5%
Typhlitis
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Syncope
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Esophageal pain
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Bone marrow hypocellular
1%
Anaphylaxis
1%
Delirium
1%
Sore throat
1%
Vasovagal reaction
1%
Anal hemorrhage
1%
Soft tissue infection
1%
Tracheitis
1%
Anal mucositis
1%
Seizure
1%
Menorrhagia
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)
Trial Design
1Treatment groups
Experimental Treatment
Group I: IMP4297(senaparib) and temozolomideExperimental Treatment1 Intervention
IMP4297 and temozolomide
Find a Location
Who is running the clinical trial?
Impact Therapeutics, Inc.Lead Sponsor
14 Previous Clinical Trials
1,491 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 many facilities are actively overseeing the progress of this experiment?
"Currently, 23 clinical sites are running this trial. They span from Seoul to Evergreen Park and Canton as well as other cities. To minimize the need for travel during your participation, we advise you pick a clinic closest to your residence."
Answered by AI
How many participants is this clinical trial currently accommodating?
"Impact Therapeutics, Inc. needs to recruit 113 suitable patients for their medical trial from diverse clinical sites including Yonsei University Health System, Severance Hospital in Seoul, Ohio and GenHarp Clinical Solutions in Evergreen Park, Tennessee ."
Answered by AI
Are there any remaining openings for individuals to join this experiment?
"Clinicaltrials.gov lists this trial as currently recruiting participants, beginning on August 7th 2020 and most recently edited September 28th 2023."
Answered by AI
What is the primary aim of this experiment?
"The key goal of this clinical trial - assessed over the duration from consent to safety follow-up - is establishing a maximal tolerated dose (MTD) for Part I: Dose Escalation. Secondary outcomes include assessing anti-tumor activity with Progression-free survival (PFS), Duration of response (DoR), and Disease control rate (DCR). Additionally, there will be assessments on the effect that IMP4297 has on QT intervals as well as measuring safety and tolerability via reported adverse events, vital signs, physical examinations, electrocardiograms, laboratory tests etc. in Part II: Dose Expansion"
Answered by AI
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