Puma Biotechnology

28 total trials 2 currently recruiting 24 completed

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.

Trial Pipeline

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 the Pipeline for Puma Biotechnology Shows

According to the ClinicalTrials.gov registry, Puma Biotechnology is linked to 28 US clinical trials across every stage of research activity. Of those, 2 studies are currently recruiting, about 7% of the sponsor's indexed portfolio, and 24 are already marked complete, representing roughly 86% of the total.

The phase mix for Puma Biotechnology reports 2 late-stage studies (Phase 3 and Phase 4 combined) and 24 earlier-phase studies (Phase 1 and Phase 2).

The top therapeutic focus area indexed for Puma Biotechnology is Breast Cancer with 3 linked trials, and 7 other condition areas appear in the top list above.

How to read these pipeline numbers

Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.

A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.

That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.