A Phase 2 interventional study of Alisertib and Alisertib in Small Cell Lung Cancer ( SCLC ), sponsored by Puma Biotechnology, Inc.. Recruiting at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Puma Biotechnology, Inc. · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to determine how well people tolerate treatment with alisertib at different doses when it is used together with paclitaxel to treat people with SCLC. The main question it aims to answer is:
The study will consist of different groups, called cohorts, in which alisertib will be studied at increasing doses. Participants in the first group, Cohort 1, will take 30 mg of alisertib by mouth 2 times a day. The dose will increase by 10 mg 2 times a day for each new cohort of participants joining the study. Side effects will be checked during the study, and the decision to increase the dose of alisertib will be based on the specific side effects experienced during the first 21 days of treatment for each cohort.
Participants will:
This is a Phase 2 open label study evaluating increasing doses of alisertib administered in combination with paclitaxel in patients with pathologically confirmed small cell lung cancer (SCLC) following progression on or after treatment with up to 2 prior treatment regimens. Patients must have received treatment with platinum-based chemotherapy and an anti-programmed death receptor 1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) immunotherapy agent. Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Starting with alisertib 30 mg twice a day (BID) in Cohort 1 and increasing in each successive cohort by 10 mg BID, each dosing cohort will enroll approximately 10 safety-evaluable patients to assess safety. Toxicity will be assessed throughout the study using NCI CTCAE v5.0, and decisions regarding escalating the alisertib dose will be based on the occurrence of Events during Cycle 1 (Days 1-21) of each dose level. If 3 or fewer patients experience an Event during Cycle 1, then the alisertib dose may be increased by 10 mg BID at the next dose level. It is not anticipated that the planned dosage of alisertib would exceed 70 mg BID. At the time 10 patients have completed Cycle 1 or the maximum number (4) of Events has been reached, whichever is sooner, the Sponsor will hold enrollment until a decision on moving to the next dose level is made.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.
This study's planned enrollment of 50 is below the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Puma Biotechnology, Inc. is the lead sponsor of 38 studies on the registry; 3 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1.
Drug: Alisertib · Drug: Paclitaxel
Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1.
Drug: Alisertib · Drug: Paclitaxel
Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1.
Drug: Alisertib · Drug: Paclitaxel
Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1.
Drug: Alisertib · Drug: Paclitaxel
Approximately ten participants will be enrolled in the cohort.
Drug: Alisertib · Drug: Paclitaxel
Alisertib enteric-coated tablets, 30 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Also known as: PB-8237, MLN8237
Alisertib enteric-coated tablets, 40 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Also known as: PB-8237, MLN8237
Alisertib enteric-coated tablets, 50 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Also known as: PB-8237, MLN8237
Alisertib enteric-coated tablets, 60 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Also known as: PB-8237, MLN8237
Alisertib enteric-coated tablets, 70 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Also known as: PB-8237, MLN8237
60 mg/m\^2 IV on Days 1 and 8 of every 21-day cycle
Percentage of Participants with Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after the last dose.
Time frame: From date of first dose through last dose plus 28 days, assessed up to 24 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants demonstrating a confirmed Complete or Partial Response during the treatment phase of the study.
Time frame: From date of first dose to first confirmed Complete or Partial Response, assessed up to 24 months
Duration of response (DOR)
DOR is measured from the time at which measurement criteria are first met for confirmed Complete or Partial Response (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
Time frame: From start date of response to first PD or death, assessed up to 24 months
Disease Control Rate (DCR)
DCR is defined as the proportion of patients who achieve overall tumor response (confirmed Complete or Partial Response) or Stable Disease lasting for at least 12 weeks from first dose of investigational product.
Time frame: From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 24 months
Progression Free Survival (PFS)
PFS is measured in months and based on the local tumor assessment. The time interval from the date of first dose until the first date on which recurrence, progression, or death due to any cause, is documented.
Time frame: From date of first dose to date of recurrence, progression or death, assessed up to 24 months
Overall Survival (OS)
OS is defined as the time from date of first dose to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
Time frame: From date of first dose to death, assessed up to 24 months
Plan to share: Yes — Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge. In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings. Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information. Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
Access criteria: Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest. Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: MLN 8237 · Paclitaxel