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PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alisertib | Experimental | 50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) or 70 mg (Amendment 3 or later) of alisertib PO BID on days 1-7 of each 21-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alisertib | Drug | Alisertib enteric-coated tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) within biomarker-defined subgroup | Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study | From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months |
| Duration of response (DOR) within biomarker-defined subgroup | Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented. | From start date of response (after date of first dose) to first PD, assessed up to 36 months |
| Disease Control Rate (DCR) within biomarker-defined subgroup | Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 weeks from first dose of investigational product. | From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months |
| Progression Free Survival (PFS) within biomarker-defined subgroup | Progression Free Survival (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. | From date of first dose to date of recurrence, progression or death, assessed up to 36 months |
| Overall Survival (OS) within biomarker-defined subgroup | Overall survival (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) in the enrolled patient population | Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study. | From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Puma Biotechnology, Inc. Clinical Operations Senior Director | Contact | (424) 248-6500 | ClinicalTrials@pumabiotechnology.com |
| Name | Affiliation | Role |
|---|---|---|
| Chief Scientific Officer | Puma Biotechnology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center | Recruiting | Daphne | Alabama | 36526 | United States | |
| The Oncology Institute of Hope and Innovation |
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.
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.
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.
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| From date of first dose to death, assessed up to 36 months |
| Duration of response (DOR) in the enrolled patient population |
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented. |
| From start date of response (after date of first dose) to first PD, assessed up to 36 months |
| Disease Control Rate (DCR) in the enrolled patient population | Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 weeks from first dose of investigational product. | From date of first dose to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 36 months |
| Progression Free Survival (PFS) in the enrolled patient population | Progression Free Survival (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. | From date of first dose to date of recurrence, progression or death, assessed up to 36 months |
| Overall Survival (OS) in the enrolled patient population | Overall survival (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. | From date of first dose to death, assessed up to 36 months |
| Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the enrolled patient population | Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose. | From date of first dose through last dose plus 28 days, assessed up to 36 months |
| Recruiting |
| Long Beach |
| California |
| 90805 |
| United States |
| Rocky Mountain Cancer Centers | Recruiting | Lone Tree | Colorado | 80124 | United States |
| Georgetown Lombardi Cancer Center | Recruiting | Washington D.C. | District of Columbia | 20057 | United States |
| Clermont Oncology Center | Recruiting | Clermont | Florida | 64711 | United States |
| The Oncology Institute of Hope and Innovation | Recruiting | Fort Lauderdale | Florida | 33316 | United States |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| Illinois Cancer Specialists | Recruiting | Niles | Illinois | 60714 | United States |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
| University of Maryland Greenebaum Comprehensive Cancer Center | Recruiting | Baltimore | Maryland | 21201 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
| Minnesota Oncology Hematology | Recruiting | Burnsville | Minnesota | 55337 | United States |
| Nebraska Cancer Specialists | Recruiting | Grand Island | Nebraska | 68803 | United States |
| Oncology Hematology Care Clinical Trials | Recruiting | Cincinnati | Ohio | 45226 | United States |
| University Hospital - Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Active, not recruiting | Cleveland | Ohio | 44195 | United States |
| Zangmeister Cancer Center | Recruiting | Columbus | Ohio | 43219 | United States |
| Oncology Associates of Oregon | Recruiting | Eugene | Oregon | 97401 | United States |
| UPMC Hillman Cancer Center | Withdrawn | Pittsburgh | Pennsylvania | 15232 | United States |
| Medical University of South Carolina Hollings Cancer Center | Recruiting | Charleston | South Carolina | 29425 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Recruiting | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
| Oncology & Hematology Associates of Southwest Virginia | Recruiting | Blacksburg | Virginia | 24073 | United States |
| Universtity of Virginia Health System | Completed | Charlottesville | Virginia | 22908 | United States |
| Virginia Cancer Specialists Research Institute | Recruiting | Fairfax | Virginia | 22031 | United States |
| Northwest Cancer Specialists | Recruiting | Vancouver | Washington | 98686 | United States |
| Marshfield Medical Center | Recruiting | Marshfield | Wisconsin | 54449 | United States |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C550258 | MLN 8237 |
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