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alisertib

alisertib: sourced relationships with 1 company · 5 clinical trials tracked.

alisertib evidence translation

What we can confirm

What it means

Source-backed records connect alisertib to PBYI; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could alisertib → PBYI affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Related indications

Small Cell Lung Cancer ( SCLC ); Hormone Receptor Positive HER-2 Negative Breast Cancer; Small Cell Lung CancerMetastatic Breast Cancer

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
PUMA BIOTECHNOLOGY, INC. (PBYI)
developer · Reported 2023-11-02 · Current development: unknownSource
Small Cell Lung Cancer ( SCLC ); Hormone Receptor Positive H…
Phase 2
Clinical Trial Registry Records (5)

A Phase 2 Study of Alisertib in Combination With Paclitaxel in Patients With Small Cell Lung Cancer

NCT07465757Registry updated 2026-09-30·Phase 2·PBYI
Recruiting

Primary endpoint: Percentage of Participants with Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)

Interventionalopen50 targetStarted 2026-09Completion 2028-097 sites · SpainPuma Biotechnology, Inc.

A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

NCT06369285Registry updated 2026-10-01·Phase 2·PBYI
Recruiting

Primary endpoint: Objective Response Rate (ORR) Within Dose Subgroup

InterventionalRandomizedopen225 targetStarted 2024-11Completion 2029-0653 sites · Portugal, Spain, United StatesPuma Biotechnology, Inc.

A Phase 2 Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

NCT06095505Registry updated 2026-08-17·Phase 2·PBYI
Recruiting

Primary endpoint: Objective response rate (ORR) within biomarker-defined subgroup

Interventionalopen120 targetStarted 2024-02Completion 2028-0430 sites · United StatesPuma Biotechnology, Inc.

A Phase I/Ib Study of Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer

NCT04085315Registry updated 2026-08-11·Phase 1
Completed

Primary endpoint: Determination of Maximum Tolerated Dose (MTD) (Cohort A)

Interventionalopen23 enrolledStarted 2019-11Completion 2025-101 site · United StatesCollin Blakely

Randomized Phase II Trial to Evaluate Alisertib Alone or Combined With Fulvestrant for Women With Advanced, Endocrine-Resistant Breast Cancer

NCT02860000Registry updated 2026-02-10·Phase 2
Active, not recruiting

Primary endpoint: Tumor Response Rate Defined as 100% Times the Number of Patients Who Meet the Criteria for Complete Response (CR) or Partial Response (PR) Using RECIST Criteria Version 1.1

InterventionalRandomizedopen96 targetStarted 2017-07Completion 2026-128 sites · United StatesMayo Clinic

Frequently asked questions

Which companies have sourced relationships with alisertib?

alisertib has dated SEC/FDA relationship records for PUMA BIOTECHNOLOGY, INC..

How many clinical trials involve alisertib?

BioSniper tracks 5 clinical trials involving alisertib.