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Cyclin-dependent kinase (CDK) inhibitor
Xentuzumab + Abemaciclib for Breast Cancer
Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have either measurable disease or non-measurable bone only disease. Measurable and non-measurable diseases are defined according to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1 [v1.1]. Non-measurable bone only disease may include any of the following: blastic bone lesions, lytic bone lesions without a measurable soft tissue component, or mixed lytic-blastic bone lesions without a measurable soft tissue component
Signed and dated written informed consent in accordance with GCP (Good Clinical Practice ) and local legislation prior to admission to the trial
Must not have
Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis
Refractory nausea and vomiting, chronic GI diseases, inability to swallow the product, or previous significant bowel resection that would preclude adequate absorption of abemaciclib or resulting in baseline Grade 2 or higher diarrhoea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the combination of two drugs, xentuzumab and abemaciclib, to see if they are safe and effective at shrinking tumors in patients with lung and breast cancer.
Who is the study for?
Adults with stage IV NSCLC or breast cancer who have tried certain treatments without success can join. They must be able to swallow pills, have no other cancers in the last 3 years, and not need drugs that could interfere with the trial. Women must not be pregnant and use birth control; men also need to use effective contraception.
What is being tested?
The study is testing Xentuzumab combined with Abemaciclib, plus hormonal therapies for some breast cancer patients. It aims to find a safe dosage while checking if these medicines shrink tumors. Participants will receive regular health checks and tumor size assessments.
What are the potential side effects?
Possible side effects include digestive issues like nausea and diarrhea, blood disorders such as low white cell counts increasing infection risk, liver function changes, potential allergic reactions to drug components, fatigue, and possibly uncontrolled blood sugar levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured by scans or is only in my bones without spreading to soft tissues.
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I have signed and understand the consent form for this trial.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have tried all treatments for my condition without success or cannot tolerate them.
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I have at least one cancer lesion that can be measured with scans.
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My lung cancer is at stage IV, confirmed by lab tests.
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My cancer is advanced, cannot be surgically removed, and was confirmed by lab tests.
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I am willing to use effective birth control during and 3 weeks after the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a known kidney condition such as glomerulonephritis or Fanconi Syndrome.
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I have severe nausea, vomiting, GI issues, trouble swallowing, or had a major bowel surgery affecting drug absorption.
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I have or had cancer spread to my brain or spinal cord.
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I haven't had cancer treatment or investigational drugs in the last 3 weeks.
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My blood counts and organ functions do not meet the required levels for the trial.
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I have Type I diabetes or my Type II diabetes is not well-controlled (HgBA1C > 8%).
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My advanced cancer has spread to vital organs and is causing severe symptoms.
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I have had a stem cell or bone marrow transplant.
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I haven't had major surgery in the last 28 days and don't plan any during the study.
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I do not have an active infection needing IV treatment or a known virus like HIV or hepatitis.
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I am not pregnant, nursing, nor planning to become pregnant or father a child during the trial.
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I have previously been treated with CDK inhibitors.
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I am allergic to xentuzumab, abemaciclib, letrozole/anastrozole/fulvestrant, or loperamide.
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I need to keep taking certain medications that may affect the trial.
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I don't have severe side effects from past treatments, except for possible mild nerve issues or hair loss.
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I have been treated with drugs targeting IGF-1R before.
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I have high blood sugar or severe diarrhea before starting treatment.
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I am not on medication that affects liver enzyme levels.
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I have been treated with specific cancer drugs, but not palbociclib or ribociclib.
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I have had radiation therapy to a large portion of my bone marrow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2022 Phase 2 trial • 103 Patients • NCT0365913656%
Diarrhoea
44%
Fatigue
40%
Headache
36%
Decreased appetite
36%
Nausea
32%
Arthralgia
30%
Mucosal inflammation
30%
Epistaxis
28%
Stomatitis
26%
Rash
26%
Cough
24%
Muscle spasms
22%
Thrombocytopenia
20%
Asthenia
20%
Hyperglycaemia
20%
Anaemia
20%
Pruritus
20%
Dysgeusia
18%
Neutropenia
18%
Vomiting
18%
Urinary tract infection
18%
Dizziness
18%
Platelet count decreased
16%
Alanine aminotransferase increased
16%
Dyspnoea
14%
Blood creatine phosphokinase increased
14%
Contusion
14%
Pain in extremity
14%
Insomnia
14%
Abdominal pain upper
14%
Pyrexia
14%
Weight decreased
12%
Dry skin
12%
Hypercholesterolaemia
12%
Hypokalaemia
12%
Gamma-glutamyltransferase increased
12%
Myalgia
12%
Paraesthesia
12%
Erythema
12%
Hypertension
10%
Blood creatinine increased
10%
Constipation
10%
Aspartate aminotransferase increased
10%
Oropharyngeal pain
10%
Abdominal pain
10%
Dry mouth
10%
Hypertriglyceridaemia
10%
Pneumonitis
10%
Alopecia
10%
Vertigo
10%
Dry eye
10%
Influenza like illness
10%
Glycosylated haemoglobin increased
8%
Neck pain
8%
Blood cholesterol increased
8%
Blood calcium decreased
8%
Neutrophil count decreased
8%
Dyspepsia
8%
Bone pain
8%
Dysuria
8%
Pollakiuria
8%
Dermatitis acneiform
8%
Oedema peripheral
8%
Blood triglycerides increased
8%
Hypophosphataemia
8%
Blood glucose increased
6%
Lymphocyte count decreased
6%
Pain
6%
Ear pain
6%
Lacrimation increased
6%
Oral pain
6%
Toothache
6%
Chest pain
6%
Upper respiratory tract infection
6%
Fall
6%
Hypocalcaemia
6%
Back pain
6%
Musculoskeletal chest pain
6%
Tremor
6%
Pelvic pain
6%
Pleural effusion
6%
Rash maculo-papular
6%
Blood albumin decreased
6%
Pain in jaw
6%
Peripheral sensory neuropathy
6%
Nasal dryness
6%
Angioedema
4%
Blood lactate dehydrogenase increased
4%
White blood cell count decreased
4%
Dehydration
4%
Anxiety
2%
Cardiac failure
2%
Depression
2%
Generalised oedema
2%
Renal failure
2%
Jugular vein thrombosis
2%
Liver injury
2%
Proteinuria
2%
Pneumonia
2%
Tongue abscess
2%
Goitre
2%
Appendicitis
2%
Mental status changes
2%
Cellulitis
2%
Febrile neutropenia
2%
Spinal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + 10 mg Everolimus + 25 mg Exemestane
1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Cohort FExperimental Treatment3 Interventions
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)
Group II: Cohort EExperimental Treatment2 Interventions
Xentuzumab + Abemaciclib (Dose 1)
Group III: Cohort D2Experimental Treatment3 Interventions
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)
Group IV: Cohort D1Experimental Treatment3 Interventions
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)
Group V: Cohort DExperimental Treatment3 Interventions
Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)
Group VI: Cohort CExperimental Treatment3 Interventions
Xentuzumab + Abemaciclib + Anastrozole (Dose 3)
Group VII: Cohort BExperimental Treatment3 Interventions
Xentuzumab + Abemaciclib + Letrozole (Dose 2)
Group VIII: Cohort AExperimental Treatment2 Interventions
Xentuzumab + Abemaciclib (Dose 1)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrozole
2016
Completed Phase 4
~5550
Xentuzumab
2017
Completed Phase 2
~240
Letrozole
2002
Completed Phase 4
~3150
Fulvestrant
2011
Completed Phase 3
~4030
Abemaciclib
2019
Completed Phase 2
~1890
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,554 Previous Clinical Trials
15,897,161 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by scans or is only in my bones without spreading to soft tissues.I have a known kidney condition such as glomerulonephritis or Fanconi Syndrome.I have severe nausea, vomiting, GI issues, trouble swallowing, or had a major bowel surgery affecting drug absorption.I don't have active brain or spinal issues from my cancer.I have or had cancer spread to my brain or spinal cord.You have experienced a relapse with specific evidence of progression according to the described timeline, and have received limited prior treatments for advanced/metastatic disease. For cohort D1, you must have a documented visceral metastasis, while for cohort D2, you must not have any visceral metastasis.I haven't had cancer treatment or investigational drugs in the last 3 weeks.My blood counts and organ functions do not meet the required levels for the trial.You have a disease that can be measured according to specific guidelines.I have Type I diabetes or my Type II diabetes is not well-controlled (HgBA1C > 8%).My advanced cancer has spread to vital organs and is causing severe symptoms.I have had a stem cell or bone marrow transplant.I haven't used erythropoietin or G-CSF in the last 2 weeks.I haven't had any cancer other than my current type in the last 3 years, except for certain skin, cervical, or breast cancers that were treated.I am not pregnant, nursing, nor planning to become pregnant or father a child during the trial.I have previously been treated with CDK inhibitors.I am allergic to xentuzumab, abemaciclib, letrozole/anastrozole/fulvestrant, or loperamide.I started taking bisphosphonates or RANK-L targeted agents less than a week ago.I am at least 18 years old, or 20 if I live in Japan.I have signed and understand the consent form for this trial.I am fully active or restricted in physically strenuous activity but can do light work.I have tried all treatments for my condition without success or cannot tolerate them.My cancer has worsened after specific treatments, and I've had limited chemotherapy options.My blood, kidney, and liver functions are all within normal ranges.I am not pregnant and agree to use birth control during and after the study.I have a history of serious heart conditions but my atrial fibrillation has been controlled for over 30 days.I haven't had major surgery in the last 28 days and don't plan any during the study.I do not have an active infection needing IV treatment or a known virus like HIV or hepatitis.I am postmenopausal due to surgery, natural causes, or treatment.I've had up to 2 chemotherapy treatments for my cancer after it spread.I have at least one cancer lesion that can be measured with scans.My lung cancer is at stage IV, confirmed by lab tests.I need to keep taking certain medications that may affect the trial.My cancer is advanced, cannot be surgically removed, and was confirmed by lab tests.I do not have severe lung problems or other serious health issues that require constant care.I don't have severe side effects from past treatments, except for possible mild nerve issues or hair loss.I have been treated with drugs targeting IGF-1R before.I have high blood sugar or severe diarrhea before starting treatment.I am not on medication that affects liver enzyme levels.I have been treated with specific cancer drugs, but not palbociclib or ribociclib.I am willing to use effective birth control during and 3 weeks after the study.I can swallow pills.I have had radiation therapy to a large portion of my bone marrow.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
- Group 3: Cohort C
- Group 4: Cohort D
- Group 5: Cohort E
- Group 6: Cohort F
- Group 7: Cohort D1
- Group 8: Cohort D2
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.