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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
Must not have
Patients with a previously documented diagnosis of myelodysplastic syndrome (MDS)
Patients who have previously received PARP inhibitors
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

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.
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.
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 below
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I have an advanced cancer that doesn't respond to standard treatments.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with myelodysplastic syndrome before.
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I have taken PARP inhibitors before.
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I still have side effects from cancer treatment, except for hair loss.
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I do not have serious heart conditions or recent major heart events.
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I cannot swallow pills or have a stomach condition that affects medication absorption.
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I have a history of seizures.
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I have had a bone marrow transplant.
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I have not taken strong CYP3A4 drugs recently or need them during the study.
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I haven't had a live-virus vaccine in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the initiation of study drugs until the end of dose escalation phase(approximately 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of study drugs until the end of dose escalation phase(approximately 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part I: Dose Escalation MTD
Part I: Dose Escalation RP2D
Part I: Dose Escalation safety and tolerability
+1 more
Secondary study objectives
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 more

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314
36%
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%
Mucositis oral
9%
Anemia
9%
Vomiting
9%
Aspartate aminotransferase increased
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%
Typhlitis
5%
Anxiety
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%
Blood bilirubin increased
3%
Lymphocyte count decreased
3%
Syncope
3%
Wound infection
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Vulval infection
2%
Upper gastrointestinal hemorrhage
2%
Thromboembolic event
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%
Ascites
1%
Soft tissue infection
1%
Bone marrow hypocellular
1%
Gastrointestinal disorders - Other, specify
1%
Vasovagal reaction
1%
Hepatobiliary disorders - Other, specify
1%
Heart failure
1%
Penile pain
1%
Delirium
1%
Esophageal pain
1%
Anal mucositis
1%
Menorrhagia
1%
Sore throat
1%
Anaphylaxis
1%
Vascular disorders - Other, specify
1%
Anal hemorrhage
1%
Tracheitis
1%
Seizure
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
~0 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
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