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Anti-mitotic agent
Alisertib for Small Cell Lung Cancer (ALISCA-Lung1 Trial)
Phase 2
Recruiting
Research Sponsored by Puma Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed ES-SCLC
Progression on or after first-line platinum-based chemotherapy. Patients must have also received a prior anti-PDL-1 immunotherapy agent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose to death, assessed up to 36 months
Awards & highlights
ALISCA-Lung1 Trial Summary
This trial is studying how safe & effective alisertib is in treating patients with advanced small cell lung cancer after first-line treatment. They'll also look for biomarkers to identify subgroups who may benefit most.
Who is the study for?
This trial is for adults over 18 with extensive-stage small cell lung cancer (ES-SCLC) who have already tried platinum-based chemotherapy and an anti-PDL-1 immunotherapy agent but the cancer has progressed. People can't join if they've previously been treated with AURKA or pan-Aurora-targeted agents, including alisertib.Check my eligibility
What is being tested?
The study is testing the effectiveness of a drug called Alisertib in patients whose ES-SCLC has worsened despite initial treatments. It aims to understand how safe Alisertib is, how it affects the body, and which specific patient groups might benefit most from it.See study design
What are the potential side effects?
While not explicitly listed here, side effects of Alisertib may include typical reactions to cancer medications such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, and potential liver toxicity.
ALISCA-Lung1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of small cell lung cancer confirmed by a lab test.
Select...
My cancer progressed after first-line platinum chemotherapy and I've had anti-PDL-1 treatment.
Select...
I am 18 years old or older.
ALISCA-Lung1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first dose to death, assessed up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose to death, assessed up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Control Rate (DCR) within biomarker-defined subgroup
Duration of response (DOR) within biomarker-defined subgroup
Objective response rate (ORR) within biomarker-defined subgroup
+2 moreSecondary outcome measures
Disease Control Rate (DCR) in the enrolled patient population
Duration of response (DOR) in the enrolled patient population
Objective response rate (ORR) in the enrolled patient population
+3 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%
Neutropenic sepsis
2%
Pulmonary embolism
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
ALISCA-Lung1 Trial Design
1Treatment groups
Experimental Treatment
Group I: AlisertibExperimental Treatment1 Intervention
50 mg of alisertib PO BID on days 1-7 of each 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alisertib
2010
Completed Phase 2
~1140
Find a Location
Who is running the clinical trial?
Puma Biotechnology, Inc.Lead Sponsor
57 Previous Clinical Trials
9,882 Total Patients Enrolled
Chief Scientific OfficerStudy DirectorPuma Biotechnology, Inc.
8 Previous Clinical Trials
1,552 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Alisertib attained governmental authorization for use?
"There is limited clinical evidence to suggest Alisertib's safety, therefore it was given a rating of 2."
Answered by AI
Are volunteers being enrolled in this experimentation currently?
"Unfortunately, according to clinicaltrials.gov records this trial is no longer recruiting patients since it was last updated on October 18th 2023. However, there are currently over 1500 other trials looking for volunteers right now."
Answered by AI
What is the desired outcome of this research endeavor?
"According to the study sponsor, Puma Biotechnology Inc., this trial will predominantly measure Duration of Response (DOR) within a biomarker-defined subgroup over 36 months. Furthermore, secondary goals encompass DOR in enrolled participants from first dose until documented recurrence or progressive disease; Disease Control Rate (DCR) representing patients who have achieved overall tumor response; and Progression Free Survival (PFS), with findings based on local tumour assessment."
Answered by AI
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