A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)
ConditionSmall Cell Lung Cancer ( SCLC )
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPuma Biotechnology, Inc.
About this trial
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:
* What percentage of side effects, both mild and serious, do participants experience when being treated with alisertib and paclitaxel based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0)?
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:
* take alisertib by mouth on their own 2 times a day from Day 1 through Day 7 of each 21-day cycle and will be given paclitaxel intravenously at a dose of 60 mg/m2 on Day 1 and Day 8 of each 21-day cycle. * be given a preventive treatment to increase their body defenses, called granulocyte-colony stimulating factor (G-CSF). Study staff will give G-CSF after the last dose of alisertib or paclitaxel of each 21-day cycle in which alisertib was given. * provide blood samples to evaluate the different levels of alisertib in the blood at different times. Blood samples will be collected on Days 1 and 7 of the first and second 21-day cycles of treatment. * be treated with alisertib and paclitaxel until death, worsening of the disease, unacceptable toxicity, unwillingness to continue participating in the trial, or other criteria that requires participants to stop treatment and participation in the study. * be contacted every 8 weeks after stopping alisertib and paclitaxel treatment as part of a specific study phase called the long-term follow-up period. This will last until death, unwillingness to continue participating in the trial, or until the end of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years at signing of informed consent
Pathologically confirmed SCLC
Prior treatment with one platinum-based chemotherapy and an anti-PD-1/PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to 2 prior treatment regimens
Measurable disease as defined by RECIST v1.1
Disqualifiers
Prior treatment with an aurora kinase A (AURKA) specific-targeted or pan-Aurora- targeted agent, including alisertib, in any setting
Trial design
Design model
Sequential
Treatments tested in this trial
Alisertib
DrugAlisertib enteric-coated tablets, 30 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Alisertib
DrugAlisertib enteric-coated tablets, 40 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Alisertib
DrugAlisertib enteric-coated tablets, 50 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Alisertib
DrugAlisertib enteric-coated tablets, 60 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Alisertib
DrugAlisertib enteric-coated tablets, 70 mg BID self-administered orally on Days 1-7 of every 21-day cycle
Paclitaxel
Drug60 mg/m\^2 IV on Days 1 and 8 of every 21-day cycle
Treatment groups
50 Participants
are divided into 5 treatment groupsGroup A: Cohort 1: Alisertib 30 mg BID + PaclitaxelExperimental treatment 2 interventions
Group B: Cohort 2: Alisertib 40 mg BID + PaclitaxelExperimental treatment 2 interventions
Group C: Cohort 3: Alisertib 50 mg BID + PaclitaxelExperimental treatment 2 interventions
Group D: Cohort 4: Alisertib 60 mg BID + PaclitaxelExperimental treatment 2 interventions
Group E: Cohort 5: Alisertib 70 mg BID + PaclitaxelExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov