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.

Start Date17 Sep 2026

Sponsor / Collaborator

Puma Biotechnology, Inc.

NCT07706179

/ Not yet recruitingPhase 2IIT

Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast Cancer: A Biomarker-Driven Pilot Clinical Trial

The goal of this clinical trial is to learn if alisertib in addition to usual care works to treat HR+/HER2+ breast cancer. The main questions it aims to answer are:
* Does alisertib stop the communication between HR and HER2?
* Are there genetic markers that predict how well someone's cancer will respond to alisertib?
Participants will receive alisertib in addition to their usual care.

Start Date01 Sep 2026

Sponsor / Collaborator

University of Wisconsin-Madison

NCT06369285

/ RecruitingPhase 2

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

PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.

Start Date19 Nov 2024

Sponsor / Collaborator

Puma Biotechnology, Inc.

100 Clinical Results associated with Alisertib

100 Translational Medicine associated with Alisertib

100 Patents (Medical) associated with Alisertib

497

Literatures (Medical) associated with Alisertib

01 Sep 2026·Veterinary and Comparative Oncology

Comparative Response of Canine and Human Osteosarcoma Tumour Cell Lines to Molecularly Targeted Anticancer Agents at Clinically Relevant Exposures With Analysis of Genomic Biomarkers

Article

Author: Duval, Dawn L. ; Gustafson, Daniel L. ; Early, Kala A. ; Poplawski, Klaudia A. ; Das, Sunetra ; Morales, Maritza A.

ABSTRACT:

Osteosarcoma (OSA) is a primary bone tumour occurring in children but is also prevalent in large breed dogs. Canine OSA (cOSA) has long been viewed as analogous to human OSA (hOSA) with cOSA serving as a surrogate for development of therapeutic approaches to treat the rarer human form. Drug therapy of OSA has remained virtually unchanged over the last four decades and drug testing is challenging due to the genomic heterogeneity of OSA as well as the limited number of patients for clinical trials. Thus, an approach that includes a suitable clinical surrogate at the early stage of therapeutic development may be beneficial. Therefore, to address these challenges, a phenotypic drug screen of 12 targeted anticancer drugs was carried out using 13 cOSA and 6 hOSA cell lines and responses compared at clinically relevant exposures (CRE) estimated from human data. The results identified four drugs (alisertib, crizotinib, onvansertib and sorafenib) with significant responses at the CRE in cOSA and hOSA cell lines and demonstrated that drug responses were indistinguishable across species. Correlations of drug response with genomic biomarkers in the cOSA cell line panel identified Myc and Hedgehog signalling as potential predictors of crizotinib response and Myc, epithelial markers and anti‐apoptotic signalling for onvansertib response. The conclusions of these findings are that cOSA and hOSA cell lines show the same range of response to targeted agents and identify potential biomarker pathways for further investigation in OSA tumours for use in future comparative oncology studies including clinical trials in pet dogs.

04 Aug 2026·ACS Omega

Discovery of Novel AURKA Inhibitors for Triple-Negative Breast Cancer (TNBC) Therapy via a Hybrid Virtual Screening Pipeline, Biological Evaluation and Molecular Dynamics Simulation

Article

Author: Chen, Runmei ; Huang, Wenhai ; Zhang, Xin ; Liu, Pei ; Xu, Xiangwei ; Liu, Yanqing ; Pan, Youlu

Abstract:

Aurora kinase A (AURKA) is a pivotal driver of malignant progression and poor prognosis in triple-negative breast cancer (TNBC). In this study, we developed a cascaded AI-driven virtual screening pipeline, integrating sequence-based affinity prediction (PSICHIC), equivariant deep learning docking (KarmaDock), and geometric rescoring (DeepDock) to identify novel AURKA inhibitor candidates. From an in-house 160,000-compound screening library assembled from commercially available collections, three leads (compounds 3, 5, and 8) were selected and subsequently validated via HTRF biochemical assays, exhibiting potent enzymatic inhibition with IC50 values of 157 nM, 21.64 nM, and 46.03 nM, respectively. Cell-based assays demonstrated that compound 3 produced stronger short-term cell-growth inhibition in MDA-MB-231 (TNBC) cells compared to clinical benchmarks MLN8237 and CCT241736, whereas compounds 3 and 5 showed cell-growth inhibition in NIH/3T3 cells within the same concentration range as the reference inhibitors. Triplicate 500 ns molecular dynamics simulations supported stable binding modes of the identified leads in the AURKA binding pocket. Additional computational analyses further provided supportive information for subsequent lead optimization. This study provides a transparent and open-source workflow for AI-assisted identification of AURKA-active chemotypes.

02 Jul 2026·MOLECULAR CANCER THERAPEUTICS

Chromobox 2 Inhibition: A Novel Activity of Alisertib, an Aurora A Kinase Inhibitor

Article

Author: Nurmemmedov, Elmar ; Bitler, Benjamin G. ; Elder, Alan M. ; Petkov, Alexander ; Reigan, Philip ; Woodruff, Elizabeth R. ; Brubaker, Lindsay W. ; Eisenmesser, Elan ; Yamamoto, Tomomi M. ; Iwanaga, Ritsuko

Abstract:

Chromobox 2 (CBX2), a subunit of polycomb repressor complex 1 (PRC1), is expressed in high-grade serous carcinoma (HGSC). CBX2-inhibitory peptide (CBX2i) has demonstrated efficacy in a syngeneic mouse model but has limitations. We sought to identify an alternative approach to CBX2 inhibition. A computational-based molecular docking screen was performed using the Selleckchem Bioactive Library to identify inhibitors of CBX2. A similarity screen of top hits against the bound conformation of CBX2i pharmacophore model was performed in parallel. A series of in vitro validation studies evaluated the effect of alisertib on proliferation, a CBX2 target gene, and stemness. CBX2-knockdown cell lines and a syngeneic murine model were utilized to evaluate alisertib response in the context of CBX2 loss. Cell target engagement assay was performed. PRC1 activity was measured by H2AK119ub levels. Immune profiling of treated tumors defined the immune microenvironment. The computational-based screen identified 10 candidate compounds. In vitro validation narrowed compounds of interest to raltitrexed, alisertib, GTX-007, LY315920, and PD0325901. Ultralow dilution assay demonstrated a dramatic decrease in spheroid formation with alisertib, an aurora A kinase (AURKA) inhibitor. Good structural overlap was observed between CBX2i and alisertib. Cell target engagement assay confirmed alisertib selectivity for both AURKA and CBX2. Loss of CBX2 attenuated alisertib efficacy in vitro and in vivo. Treatment with alisertib leads to a decrease in H2AK119ub and shift in the immune tumor microenvironment. Alisertib efficacy in HGSC is dependent on functional CBX2, and cell target engagement confirms selectivity for CBX2, supporting that alisertib activity involves CBX2 inhibition.

News (Medical) associated with Alisertib

17 Sep 2026

·www.biospace.com

Puma Biotechnology Initiates ALISCA®-Lung2, a Phase II Trial of Alisertib in Combination with Paclitaxel for the Treatment of Patients with Advanced Small Cell Lung Cancer

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA ® -Lung2) Phase II trial (PUMA-ALI-4202; NCT07465757 ) of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. The ALISCA ® -Lung2 trial is a sequential dose escalation study that will enroll approximately 50 patients with small cell lung cancer who have progressed on or after treatment with platinum-based chemotherapy and immunotherapy. The primary endpoint of the trial is the safety and tolerability of alisertib when administered with paclitaxel. Secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival and overall survival. Puma will also evaluate clinical biomarkers to help identify which patients have the greatest benefit to guide the future development of alisertib. Taofeek K. Owonikoko, MD, PhD and Chair of the trial’s Steering Committee, said, “Treatment options for patients with small cell lung cancer that has progressed following platinum-based chemotherapy and immunotherapy remain limited, and there is an urgent need for new treatment approaches for these patients. I am pleased to see further evaluation of alisertib in these patients." Dr. Owonikoko is the Executive Director of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, and the Kevin J. Cullen, MD Distinguished Professor of Oncology at the University of Maryland School of Medicine. He added, “The results from previous clinical trials of alisertib in small cell lung cancer, including those in combination with paclitaxel, suggest that the drug may represent a potentially promising treatment option for these patients and, more specifically, for patient subsets whose tumors harbor potential molecular markers that are likely associated with the clinical activity of an aurora kinase A inhibitor such as alisertib.” Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, “We are pleased to initiate this Phase II trial, and we hope that the study will provide important insight into the safety and clinical activity of alisertib in combination with paclitaxel in patients with small cell lung cancer. We are continuing to advance alisertib monotherapy in the ALISCA ® -Lung1 trial as well, and we view the ALISCA ® -Lung2 trial as additive to the clinical development of alisertib in small cell lung cancer. We look forward to the progress of both the ALISCA ® -Lung1 and ALISCA ® -Lung2 trials, as well as our other ongoing clinical programs, in the months ahead.” About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. In September 2026, Puma initiated ALISCA ® -Lung2, a Phase II clinical trial of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at . Forward-Looking Statements This press release contains forward-looking statements, including statements regarding Puma’s expectations regarding the development of alisertib and clinical trials involving alisertib. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Puma’s business or the global economy and financial markets, any changes in Puma’s product candidates’ regulatory approvals, results from Puma’s clinical trials, any litigation involving Puma, any changes to Puma’s in-licensed intellectual property and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law. Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com David Schull, Russo Partners, +1 212 845 4200 david.schull@russopartnersllc.com

Phase 2Drug ApprovalLicense out/inImmunotherapy

09 Sep 2026

·www.biospace.com

Puma Biotechnology to Present at H.C. Wainwright’s 28th Annual Global Investment Conference

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder, will provide an overview of Puma at 3:30 p.m. ET on Monday, September 14, at the H.C. Wainwright 28th Annual Global Investment Conference. The conference will be held September 14-16, 2026 at the Lotte New York Palace Hotel in New York City. A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . The presentation will be archived on the website and available for 30 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at . Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com David Schull, Russo Partners, +1 212 845 4200 david.schull@russopartnersllc.com

03 Sep 2026

·www.biospace.com

Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - September 3, 2026

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on September 1, 2026, the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering 33,550 shares of Puma common stock to five new non-executive employees. The awards were granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017, and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying the award vesting on the first anniversary of the award’s vesting commencement date, September 1, 2026, and one-sixth of the shares underlying the award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The awards were granted as an inducement material to the new employees entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4). About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com

Drug ApprovalLicense out/inPhase 2

100 Deals associated with Alisertib

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KEGG	Wiki	ATC	Drug Bank
D10085	Alisertib	-	DB05220

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral T-cell lymphoma unspecified refractory	Phase 3	United States	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Australia	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Austria	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Belarus	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Belgium	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Brazil	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Bulgaria	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Canada	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Chile	Millennium Pharmaceuticals, Inc.	11 Jun 2012
Peripheral T-cell lymphoma unspecified refractory	Phase 3	Czechia	Millennium Pharmaceuticals, Inc.	11 Jun 2012

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06095505 (PUMA-ALI-4201, WCLC2026)	Phase 2	Small Cell Lung Cancer	50	Alisertib 50 mg BID	qafosgbwfo(tvuounvxnw) = sxyibklgpt lbyiywxokm (rrndxdypne ) View more	Positive	12 Sep 2026
SABCS2025	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER+/HER2-	126	Alisertib monotherapy	ovpvbmnzrp(loolxopryk) = hematologic AEs (neutropenia, leukopenia, and anemia), and fatigue. xxtbniadvu (vxctjnabki )	Positive	10 Dec 2025
				Alisertib ± fulvestrant
SNO2025	Phase 2	Rhabdoid Tumor of the CNS First line	71	Alisertib + chemotherapy + focal radiotherapy (Stratum B1)	zkggzsmxvs(cjrgpuxktd) = kkvinthmqo ytlmokwtma (tqbehfujce ) View more	Negative	19 Nov 2025
				Alisertib + chemotherapy + radiotherapy (Stratum B2)	zkggzsmxvs(cjrgpuxktd) = nbfojywnme ytlmokwtma (tqbehfujce )
NCT06369285 (ALISCA-Breast1, ASCO2025)	Phase 2	Hormone receptor positive HER2 negative breast cancer RB1 \| MYC \| TP53 ... View more	-	Alisertib 30 mg + Endocrine Therapy	ihcxoewzay(qhfjedypbf) = jrcippnkcf zfekxygfni (rulvkshkao ) View more	Positive	30 May 2025
				Alisertib 40 mg + Endocrine Therapy	ihcxoewzay(qhfjedypbf) = nmpzqnwnxd zfekxygfni (rulvkshkao ) View more
NCT04555837 (CTgov)	Phase 1/2	Squamous cell carcinoma of head and neck metastatic \| Squamous Cell Carcinoma of Head and Neck \| Malignant Solid Neoplasm	24	Alisertib+Pembrolizumab (Phase I)	gdoyetirwi = kbxhphvcsj waenfcjjmn (qghtllmugg, jkbunmzlnl - dlgglbwckk) View more	-	16 Dec 2024
				Alisertib+Pembrolizumab (Phase II)	zgiqfzcfit = pengwnmrxw rlojinpldj (fepjnucefv, dseeiwdutp - gbkmmyipsr) View more
NCT02860000 (TBCRC041 \| MC1431, CTgov)	Phase 2	Locally advanced breast cancer \| Metastatic breast cancer \| Hormone refractory breast cancer ... View more	96	Laboratory Biomarker Analysis+Alisertib (Arm I (Alisertib))	jkljabrpoh = spdouyzkrm lxvcoqqrkd (yztfsacdan, qqcuewynos - kobvdryxsv) View more	-	18 Oct 2024
				Laboratory Biomarker Analysis+Alisertib+Fulvestrant (Arm II (Alisertib, Fulvestrant))	jkljabrpoh = gyjatiqmit lxvcoqqrkd (yztfsacdan, gxolpfrxjj - uzjtoecwjy) View more
NCT02187991 (CTgov)	Phase 2	Metastatic breast cancer	169	Paclitaxel (ER+/HER2- Paclitaxel Alone)	drdewlvogk(esdoxnhwut) = kckfzhqugr rmieektroj (mbklepfwuw, sdkbptbbhj - lumbjqwpim) View more	-	09 Oct 2024
				Alisertib+Paclitaxel (ER+/HER2- Paclitaxel Plus Alisertib)	drdewlvogk(esdoxnhwut) = kkyfblnyls rmieektroj (mbklepfwuw, ideiafwdug - naeqecvdhi) View more
NCT04085315 (phase I/Ib study, ASCO2024) Manual	Phase 1	EGFR Mutation Lung Cancer EGFR	21	alisertib+osimertinib	wbhxzvkbkz(bkzblgomaj) = neutropenia (42.9%), anemia (42.9%), and diarrhea (38.1%) vkotrrmmzh (ypjvwnwsou )	Positive	24 May 2024
NCT02860000 (TBCRC041, ASCO2024)	Phase 2	Metastatic breast cancer ESR1 \| PIK3CAmutation \| AKT1 ... View more	91	Alisertib + Fulvestrant	wmmyywklpr(zrhmmkntuz): HR = 1.8 (95% CI, 1.1 - 2.9), P-Value = 0.014	Positive	24 May 2024
				Alisertib
NCT02187991 (ASCO2023) Manual	Phase 2	Metastatic Triple-Negative Breast Carcinoma \| Hormone receptor positive HER2 negative breast cancer HR Positive \| PR Negative \| ER Negative \| ... View more	96	alisertib (A) combined with paclitaxel (P) or P alone	qvwvlmxoyl(ukqhesblxd) = pbjgnfesdq wuswjupqap (zenbezjemb )	Positive	31 May 2023

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