Puma Biotechnology

Open enrollment with an early-phase pipeline tilt

According to ClinicalTrials.gov-derived indexes, Puma Biotechnology sits in the top decile of US sponsors by registered trial count (#568 of 15,742 sponsors by registered trial count).

28 total trials 2 currently recruiting 24 completed early-phase tilt top decile by trial count

Puma Biotechnology: 28 sponsored US clinical trials, 2 recruiting.

Puma Biotechnology sponsors 28 registered US clinical trials on ClinicalTrials.gov, 2 of them currently recruiting, and 24 completed. 2 of these trials are in Phase 3-4 (later-stage) and 24 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Breast Cancer, with 3 trials.

Top-decile sponsor footprint

Puma Biotechnology ranks in the top decile of sponsors by registered trial count (#568 of 15,742 sponsors by registered trial count). Volume at this scale usually reflects a long institutional pipeline, read phase tilt and therapeutic areas below before treating it as current-year activity.

Trial completion reliability score

C 71/100

24 of 26 decided trials (Completed vs. Terminated on ClinicalTrials.gov) reached their planned completion (92.3%), vs. national p10 68.4% / p90 100% among 1,234 sponsors with at least 10 decided trials. Still-open trials (Recruiting, Active-not-recruiting, Not-yet-recruiting) are excluded since they have not reached an outcome yet.

Open and recent trials

28 total, page 1 of 1

RECRUITING Phase 2

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

NCT06369285

RECRUITING Phase 2

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

NCT06095505

TERMINATED

HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

NCT03786107

COMPLETED Phase 2

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

NCT02400476

COMPLETED Phase 1

Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects

NCT02334501

TERMINATED Phase 2

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

NCT01953926

COMPLETED Phase 2

Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

NCT01827267

COMPLETED Phase 3

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

NCT01808573

COMPLETED

A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

NCT01142063

COMPLETED Phase 1

Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

NCT01111825

COMPLETED Phase 2

Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

NCT00915018

COMPLETED Phase 3

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

NCT00878709

COMPLETED Phase 1

Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

NCT00838539

COMPLETED Phase 1

Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin

NCT00860223

COMPLETED Phase 1

Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib

NCT00864487

COMPLETED Phase 2

Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

NCT00777101

COMPLETED Phase 1

Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

NCT00814060

COMPLETED Phase 1

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

NCT00741260

COMPLETED Phase 1

Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

NCT00757809

COMPLETED Phase 1

Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)

NCT00708903

COMPLETED Phase 1

Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

NCT00706030

COMPLETED Phase 1

A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

NCT00445458

COMPLETED Phase 1

Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

NCT00498745

COMPLETED Phase 1

A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

NCT00398567

COMPLETED Phase 2

Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

NCT00300781

COMPLETED Phase 1

Study Evaluating HKI-272 Administered to Healthy Subjects

NCT00366600

COMPLETED Phase 2

Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer

NCT00266877

COMPLETED Phase 1

Study Evaluating HKI-272 in Tumors

NCT00146172

What is open in the Puma Biotechnology pipeline

2 recruiting of 28 indexed (7% open); 24 completed (86%).

Phase mix: 2 late (III/IV) vs 24 early (I/II) (early-phase heavy).

Top condition: Breast Cancer (3 trials), 7 others listed.

How open-pipeline share is computed

Recruiting share is recruiting_count divided by trial_count for this sponsor in the public registry export. Status can change between pulls; treat the figure as a research-attention snapshot, not product availability.

Puma Biotechnology: open-pipeline peers nationwide

Peers matched on 28 registered trials and 7% open enrollment, not the therapeutic-area sidebar.

Puma Biotechnology sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together. Source: ClinicalTrials.gov (2026-08-08 snapshot). 2×2 strategic matrix plotting 9 entities by Total trials (X) and Recruiting share (Y), with a crosshair dividing the plot into four quadrants. Higher volume & more openFocused & more openHigher volume, mostly closedSmaller & mostly closed 0100200300400 0%5%10%15%20%25% Total trials Recruiting share Puma BiotechnologyAxsome TherapeuticsBenaroya Research InstituteCAMC Health SystemCTI BioPharmaCarol Fabian, MDCelldex TherapeuticsKaiser PermanenteMannkind Corporation
Puma Biotechnology sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together. Source: ClinicalTrials.gov (2026-08-08 snapshot).

Puma Biotechnology sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together.

Sponsors near 28 trials (± recruiting share)

Sponsors near 7% open enrollment (± trial volume)

What to do with this Puma Biotechnology page

28 registered trials is a research-attention snapshot, not an endorsement of Puma Biotechnology or any single study.

  • 2 of Puma Biotechnology's trials are currently recruiting, check each one's own eligibility criteria before contacting a site. Browse recruiting trials
  • Breast Cancer is the condition Puma Biotechnology studies most, compare against other sponsors active in the same condition before evaluating a specific study. See Breast Cancer trials
  • Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Puma Biotechnology pipeline card: 28 registered trials from official public datasets.Report a data error.