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Aurora Kinase Inhibitor
Alisertib + Osimertinib for Lung Cancer
Phase 1
Waitlist Available
Led By Collin Blakely, MD, PhD
Research Sponsored by Collin Blakely
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Currently receiving and tolerating osimertinib 80 mg PO daily with no current grade 2 or greater AE attributable to osimertinib.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of alisertib when given with osimertinib for patients with EGFR-mutated stage IV lung cancer.
Who is the study for?
Adults with stage IV lung cancer characterized by specific EGFR mutations, who are currently taking and tolerating osimertinib. They must have good performance status, measurable disease, acceptable lab values, agree to provide samples for research, use contraception if applicable, and not be pregnant or breastfeeding. Excluded are those with certain brain metastases, extensive prior radiation therapy, severe medical conditions or those on conflicting medications.Check my eligibility
What is being tested?
This trial is testing the combination of two drugs: Alisertib (which blocks a protein that may help lung cancer grow) and Osimertinib (which targets mutant proteins to reduce tumor growth). The study aims to determine the safest dose of Alisertib when used with Osimertinib and observe their effects on advanced-stage lung cancer.See study design
What are the potential side effects?
Potential side effects include issues related to blocking Aurora Kinase A by Alisertib which could affect cell division leading to blood disorders or fatigue; while Osimertinib might cause skin reactions or diarrhea due to its action on EGFR. Both drugs' interactions can also result in unforeseen side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am taking osimertinib 80 mg daily without severe side effects.
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I am following the required contraceptive measures.
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I am following the required birth control guidelines.
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My lung cancer is confirmed to be stage IV non-small cell type.
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My cancer has a specific EGFR mutation, confirmed by a certified lab test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of Maximum Tolerated Dose (MTD)
Proportion of patients experiencing dose limiting toxicity (DLT)
Proportion of patients experiencing serious adverse event (SAE)
Secondary outcome measures
Amount of time (maximum) drug concentration in serum (Tmax)
Area Under Curve (AUC)
Central Nervous System (CNS) disease control rate
+8 moreSide effects data
From 2017 Phase 2 trial • 178 Patients • NCT0203864755%
Diarrhoea
47%
Neutropenia
44%
Anaemia
44%
Fatigue
34%
Nausea
33%
Decreased appetite
32%
Vomiting
31%
Stomatitis
24%
Dyspnoea
20%
Cough
17%
Dizziness
16%
Neutrophil count decreased
16%
Alopecia
16%
Asthenia
15%
Weight decreased
14%
Leukopenia
14%
Abdominal pain
14%
White blood cell count decreased
11%
Hypokalaemia
10%
Arthralgia
10%
Febrile neutropenia
10%
Headache
9%
Constipation
9%
Neuropathy peripheral
9%
Pyrexia
9%
Dyspepsia
8%
Thrombocytopenia
8%
Dehydration
8%
Hypocalcaemia
8%
Insomnia
8%
Abdominal pain upper
7%
Muscular weakness
7%
Oedema peripheral
6%
Dysphonia
6%
Hypomagnesaemia
6%
Dysphagia
6%
Gastrooesophageal reflux disease
6%
Fall
6%
Somnolence
6%
Back pain
6%
Hyperglycaemia
6%
Hypertension
5%
Musculoskeletal pain
5%
Hypoaesthesia
5%
Productive cough
5%
Non-cardiac chest pain
5%
Paraesthesia
3%
Epistaxis
3%
Pain in extremity
3%
Respiratory failure
3%
Pneumonia
3%
General physical health deterioration
2%
Pulmonary embolism
2%
Neutropenic sepsis
2%
Dysgeusia
2%
Confusional state
2%
Lung neoplasm malignant
2%
Upper respiratory tract infection
1%
Ataxia
1%
Seizure
1%
Acute respiratory failure
1%
Mental status changes
1%
Pulmonary oedema
1%
Embolism
1%
Pancytopenia
1%
Influenza
1%
Fungal infection
1%
Paraplegia
1%
Oral herpes
1%
Metastases to meninges
1%
Diabetic metabolic decompensation
1%
Aortic thrombosis
1%
Cardiac failure
1%
Acute coronary syndrome
1%
Bacteraemia
1%
Sepsis
1%
Septic shock
1%
Respiratory tract infection
1%
Glioblastoma
1%
Tumour pain
1%
Systemic inflammatory response syndrome
1%
Bile duct stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Paclitaxel
Alisertib + Paclitaxel
Trial Design
3Treatment groups
Experimental Treatment
Group I: Dose Expansion: Cohort BExperimental Treatment2 Interventions
Stage IV EGFR-mutant NSCLC patients who are currently receiving first line osimertinib treatment and have received at least 3 months, but no more than 6 months, of osimertinib with a best response of PR or SD. Patients may receive alisertib therapy until lack of clinical benefit or intolerable toxicity.
Group II: Dose Expansion: Cohort AExperimental Treatment2 Interventions
Stage IV EGFR-mutant NSCLC currently receiving and progressing on osimertinib who have received no more than one additional line of systemic cancer therapy other than osimertinib (e.g., chemotherapy +/- immunotherapy, amivantamab +/- Lazertinib) for metastatic disease. Patients may receive alisertib therapy until lack of clinical benefit or intolerable toxicity.
Group III: Dose Escalation (Closed to Enrollment)Experimental Treatment2 Interventions
Patients will continue to receive osimertinib 80 mg PO daily as part of standard of care therapy during screening and study treatments. Alisertib will be administered to eligible patients in combination with osimertinib at doses ranging from 20 mg to 50 mg PO twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle. The starting alisertib dose will be 30 mg twice daily (dose level 1). All patients at a given dose level must complete the DLT period before any additional cohorts can be opened.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010
Alisertib
2010
Completed Phase 2
~1140
Find a Location
Who is running the clinical trial?
Puma Biotechnology, Inc.Industry Sponsor
56 Previous Clinical Trials
9,770 Total Patients Enrolled
Collin BlakelyLead Sponsor
1 Previous Clinical Trials
33 Total Patients Enrolled
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on medication that interferes with the study drugs.I am fully active or can carry out light work.I do not have any stomach or intestine problems that could affect how a medicine is absorbed.I have uncontrolled sleep apnea or conditions causing excessive daytime sleepiness.I do not have any severe medical or mental health conditions.My cancer has spread to the lining of my brain and spinal cord.I am 18 years old or older.I am not pregnant or breastfeeding.I am a male and do not plan to donate sperm during or within 4 months after the study.I must take specific medications regularly during the study.I cannot take pills or follow the treatment plan for alisertib.I do not plan to donate eggs during or within 4 months after the study.I am taking osimertinib 80 mg daily without severe side effects.I have received radiation therapy to a large portion of my bone marrow.I have brain metastases and am not stable neurologically.You have had a bone marrow or organ transplant from someone else in the past.Your heart's electrical activity takes too long to reset.I have not been diagnosed or treated for another cancer within the last 3 years.You have a tumor that can be measured using specific guidelines for assessing the size of tumors.Your recent blood test results must be within certain normal ranges.I am following the required contraceptive measures.I am following the required birth control guidelines.Your recent imaging shows that the disease has gotten worse in the last 30 days.I have a history of serious heart conditions.My lung cancer is confirmed to be stage IV non-small cell type.My cancer has a specific EGFR mutation, confirmed by a certified lab test.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion: Cohort B
- Group 2: Dose Escalation (Closed to Enrollment)
- Group 3: Dose Expansion: Cohort A
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 is the regulatory status of Alisertib?
"Our professionals assess the safety of Alisertib to be a 1, as it is currently undergoing Phase 1 testing which reveals limited evidence regarding efficacy and security."
Answered by AI
What is the intended outcome of this experiment?
"This trial's primary goal is to measure the proportion of participants who experience dose-limiting toxicity during the initial 28 day treatment cycle. Secondary outcomes include median overall survival (calculated by Kaplan Meier analysis with 95% confidence intervals), median duration of response over a two year period, and area under curve for drug concentration in blood plasma from 0-24 hours."
Answered by AI
Could you provide a synopsis of the research conducted on Alisertib thus far?
"At present, 106 research studies into Alisertib are in progress; 17 of which have now reached Stage 3. The majority of these trials take place at the Uniondale site in New york, however there are 4,727 other locations that offer clinical testing for this drug."
Answered by AI
What is the current participation rate for this experiment?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial is in the process of recruiting applicants. It was originally posted on November 12th 2019 and most recently updated on August 10th 2022, with a goal to enroll 38 participants at one site."
Answered by AI
Is this study open to recruitment at this time?
"Affirmative. Clinicaltrials.gov confirms that this medical study, which was initially listed on November 12th 2019, is actively recruiting participants. At one site, 38 patients need to be enrolled into the trial."
Answered by AI
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