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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort F: disease control (DC) defined as best overall response of complete response (CR) or partial response (PR) or confirmed stable disease (SD) or Non-CR/ Non-PD where best overall response is defined according to RECIST version 1.1
Cohorts A, B,C & D - Maximum Tolerated Dose (MTD)
Cohorts A, B,C & D - Number of patients with dose limiting toxicities (DLT) in the Maximum Tolerated Dose (MTD) evaluation period
+2 moreSecondary outcome measures
Cohorts D1 & D2: Objective response (OR) defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
Cohorts E, D1 & D2: Disease control (DC) defined as best overall response of complete response (CR) or partial response (PR) or confirmed stable disease (SD) where best overall response is defined according to RECIST version 1.1
Cohorts E, D1 & D2: Duration of objective response defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response
+3 moreSide 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%
Contusion
14%
Pain in extremity
14%
Insomnia
14%
Abdominal pain upper
14%
Pyrexia
14%
Blood creatine phosphokinase increased
14%
Weight decreased
12%
Hypercholesterolaemia
12%
Dry skin
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%
Neutrophil count decreased
8%
Dyspepsia
8%
Bone pain
8%
Dysuria
8%
Pollakiuria
8%
Dermatitis acneiform
8%
Oedema peripheral
8%
Blood calcium decreased
8%
Blood cholesterol increased
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%
White blood cell count decreased
4%
Dehydration
4%
Blood lactate dehydrogenase increased
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
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
Letrozole
2002
Completed Phase 4
~3240
Fulvestrant
2011
Completed Phase 3
~3690
Anastrozole
2019
Completed Phase 4
~10090
Abemaciclib
2019
Completed Phase 2
~1710
Xentuzumab
2018
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,340,159 Total Patients Enrolled
3 Trials studying Tumors
1,624 Patients Enrolled for Tumors
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What indications is Xentuzumab typically prescribed for?
"Xentuzumab is a viable option for patients with advanced cancer, as well as those who have undergone 2-3 years of tamoxifen therapy or are suffering from early invasive breast cancer."
Answered by AI
Have any other investigations explored the properties of Xentuzumab?
"Currently, there are 329 studies being conducted to examine Xentuzumab's effectiveness. 72 of these active trials are in their final stage of development, Phase 3. While the majority take place in Shanghai, a total of 18927 research sites have been allocated for this investigation across numerous locations worldwide."
Answered by AI
Are there any open spots available in this clinical investigation?
"Clinicaltrials.gov reveals that this trial, initially posted on May 4th 2017 and last updated November 15th 2022, is no longer recruiting patients. However, alternative studies are currently enrolling participants; over 4800 clinical trials remain available for enrollment at present."
Answered by AI
What is the maximum allowable enrollment for this trial?
"The trial is no longer open for enrollment; it was initially posted on May 4th 2017 and its last update was November 15th 2022. However, if you are still looking to participate in a clinical study, there are 4533 studies that specialize in breast cancer research and 329 trials investigating Xentuzumab recruiting patients now."
Answered by AI
What is the current standing of Xentuzumab in terms of federal authorization?
"Taking into account the limited clinical data pertaining to xentuzumab, our Power team has assigned it a safety rating of 1."
Answered by AI
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