Abraxane

also known as ABI-007 · Abraxane, also ABI-007

Developed for: breast cancer · malignant pancreatic neoplasm · pancreatic adenocarcinoma · colorectal cancer · female breast carcinoma · metastatic melanoma · ovarian cancer · primary peritoneal carcinoma
+26 more
· adenosquamous carcinoma · basaloid squamous cell carcinoma · breast carcinoma · cancer · cancer of unknown primary site · cholangiocarcinoma · cutaneous melanoma · endometrial cancer · fallopian tube cancer · head and neck squamous cell carcinoma · HER2 positive breast carcinoma · Her2-receptor negative breast cancer · high grade malignant neoplasm · inflammatory breast carcinoma · lung cancer · male breast carcinoma · malignant epithelial tumor of ovary · malignant exocrine pancreas neoplasm · non-small cell lung carcinoma · non-small cell squamous lung carcinoma · pancreatic ductal adenocarcinoma · peritoneum cancer · prostate neoplasm · triple-negative breast carcinoma · undifferentiated carcinoma · urinary bladder cancer
Investigated by: Celgene Corporation · Abramson Cancer Center at Penn Medicine · The Methodist Hospital Research Institute · Genentech, Inc. · Zhejiang Cancer Hospital · AstraZeneca
+48 more
· Brown University · UNC Lineberger Comprehensive Cancer Center · University of Miami · Yale University · Accelerated Community Oncology Research Network · Agennix · CCTU- Cancer Theme · CSPC Ouyi Pharmaceutical Co., Ltd. · California Cancer Assocaties for Research & Excellence · Cambridge University Hospitals NHS Foundation Trust · Cancer Research UK · Columbia University · Daiichi Sankyo UK Ltd. · Dana-Farber Cancer Institute · Fondazione Michelangelo · Fujian Medical University Union Hospital · Istituto Clinico Humanitas · Jenny C. Chang, MD · Lynn E. Spitler, MD · M.D. Anderson Cancer Center · Medical University of South Carolina · Mt. Sinai Medical Center, Miami · NYU Langone Health · National Cancer Institute (NCI) · Novartis · Novotech (Australia) Pty Limited · OHSU Knight Cancer Institute · Olugbenga Olowokure · OncoMed Pharmaceuticals, Inc. · Ortho Biotech, Inc. · PD Dr. med. Volker Heinemann · Rgenix, Inc. · Rhode Island Hospital · Shandong Cancer Hospital and Institute · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Southeastern Gynecologic Oncology · Stamford Hospital · Sun Yat-sen University · Susan G. Komen Breast Cancer Foundation · Technical University of Munich · Triple Negative Breast Cancer Foundation · University of Alabama at Birmingham · University of Cologne · University of Southern California · Wake Forest University Health Sciences · West Virginia University · William Sikov MD · Yuhong Li

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansions (4)	US (FDA)	ABRAXANE	—	2007-02-15 – 2019-12-06	fda.gov ↗
Approved	EU (EMA)	Abraxane	—	2008-01-11	europa.eu ↗
Approved	US (FDA)	ABRAXANE	—	2005-01-07	fda.gov ↗

Trials 49

today

US approved 2005

EU approved 2008

NCT07284836 · Ph 2 NCT05911308 · Ph 1 NCT05828381 · Ph 2 NCT05274893 · Ph 1 NCT04639271 · Ph 2 NCT03647514 · not/applicable NCT03647280 · not/applicable NCT03158779 · Ph 2 NCT02975141 · Ph 1 NCT02744898 · Ph 2 NCT02578732 · Ph 2 NCT02581501 · Ph 1 NCT02303977 · Ph 2 NCT02328105 · Ph 2 NCT02207465 · Ph 1 NCT02124369 · Ph 2 NCT02183805 · Ph 2 NCT01938833 · Ph 1/2 NCT02142335 · Ph 2 NCT02073487 · Ph 2 NCT02027428 · Ph 3 NCT02022033 · Ph 2 NCT02073916 · Ph 1 NCT01963325 · Ph 2 NCT01839799 · Ph 2 NCT01822314 · Ph 3 NCT01730586 · Ph 2 NCT01693276 · Ph 1/2 NCT01783054 · Ph 0 NCT01446016 · Ph 2 NCT01307891 · Ph 2 NCT01189929 · Ph 1 NCT01821859 · Ph 2 NCT00583349 · Ph 1/2 NCT00723125 · Ph 2 NCT00691054 · Ph 2 NCT00667147 · Ph 1 NCT00570674 · Ph 1/2 NCT00625573 · Ph 2 NCT00521781 · Ph 2 NCT00503906 · Ph 2 NCT00472693 · Ph 2 NCT00473720 · Ph 1 NCT00462423 · Ph 2 NCT00442260 · Ph 1/2 NCT00407563 · Ph 2 NCT00466986 · Ph 2 NCT00107094 · Ph 1 NCT00520000 · Ph 1

200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT01783054	Jul 2012 → Oct 2015	pancreatic adenocarcinoma	Medical University of South Carolina	Terminated	No outcome recorded Stop: Enrollment
Phase 111 trials
Phase 1	NCT05911308	Apr → Oct 2024	non-small cell lung carcinoma	UNC Lineberger Comprehensive Cancer Center	Terminated	No outcome recorded
Phase 1	NCT05274893	Mar → Sep 2022	breast cancer	CSPC Ouyi Pharmaceutical Co., Ltd.	Unknown	No outcome recorded
Phase 1	NCT02975141	Sep 2016 → Dec 2018	pancreatic ductal adenocarcinoma	PD Dr. med. Volker Heinemann	Unknown	No outcome recorded
Phase 1	NCT02581501	Feb → Dec 2016	malignant pancreatic neoplasm	Stamford Hospital	Withdrawn	No outcome recorded Stop: Enrollment
Phase 1	NCT02207465	Jul 2014 → Dec 2026 expected	—	Abramson Cancer Center at Penn Medicine	Active not recruiting	No outcome recorded
Phase 1	NCT02073916	Oct 2013 → Dec 2018	breast cancer	Jenny C. Chang, MD	Completed	No outcome recorded
Phase 1	NCT01189929	Aug 2010 → Dec 2016	malignant pancreatic neoplasm	OncoMed Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1	NCT00667147	Mar 2008 → May 2012	cancer	University of Southern California	Completed	No outcome recorded
Phase 1	NCT00473720	May 2007 → Jun 2010	high grade malignant neoplasm	Yale University	Completed	No outcome recorded
Phase 1	NCT00107094	Mar 2005 → ?	breast cancer	Celgene Corporation	Completed	No outcome recorded
Phase 1	NCT00520000	Dec 2004 → May 2006	cancer of unknown primary site	UNC Lineberger Comprehensive Cancer Center	Completed	No outcome recorded

Phase 1/25 trials
Phase 1/2	NCT01938833	Apr 2014 → Aug 2016	Her2-receptor negative breast cancer, inflammatory breast carcinoma, male breast carcinoma	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	Terminated	No outcome recorded
Phase 1/2	NCT01693276	Sep 2012 → Jun 2014	malignant pancreatic neoplasm	Olugbenga Olowokure	Terminated	No outcome recorded Stop: Enrollment
Phase 1/2	NCT00583349	Dec 2008 → Mar 2013	urinary bladder cancer	Columbia University	Completed	No outcome recorded
Phase 1/2	NCT00570674	Nov 2007 → Oct 2013	adenosquamous carcinoma, basaloid squamous cell carcinoma, head and neck squamous cell carcinoma, undifferentiated carcinoma	Dana-Farber Cancer Institute	Terminated	No outcome recorded
Phase 1/2	NCT00442260	Feb 2007 → Oct 2008	breast cancer	West Virginia University	Completed	No outcome recorded
Phase 228 trials · 2 met primary
Phase 2	NCT07284836	Feb 2025 → Jan 2028 expected	female breast carcinoma	Zhejiang Cancer Hospital	Recruiting	No outcome recorded
Phase 2	NCT05828381	Jun 2023 → Jun 2025	—	Fujian Medical University Union Hospital	Unknown	No outcome recorded
Phase 2	NCT04639271	Jan 2021 → Jan 2022	HER2 positive breast carcinoma	Shandong Cancer Hospital and Institute	Unknown	No outcome recorded
Phase 2	NCT03158779	May 2017 → Jul 2022	malignant pancreatic neoplasm	Istituto Clinico Humanitas	Completed	No outcome recorded
Phase 2	NCT02578732	Jul 2016 → Dec 2019	malignant exocrine pancreas neoplasm	Brown University	Completed	No outcome recorded
Phase 2	NCT02744898	Jul 2016 → Aug 2018	endometrial cancer	NYU Langone Health	Completed	No outcome recorded
Phase 2	NCT02303977	Jun 2015 → Apr 2020	—	Abramson Cancer Center at Penn Medicine	Completed	No outcome recorded
Phase 2	NCT02328105	Dec 2014 → Jun 2017	lung cancer	Wake Forest University Health Sciences	Completed	No outcome recorded
Phase 2	NCT02124369	Jul 2014 → Jul 2017	pancreatic adenocarcinoma	CCTU- Cancer Theme	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT02183805	Jun 2014 → Dec 2020	breast carcinoma	Sun Yat-sen University	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT02142335	Mar 2014 → Mar 2015	cutaneous melanoma, metastatic melanoma	California Cancer Assocaties for Research & Excellence	Unknown	No outcome recorded
Phase 2	NCT02022033	Feb 2014 → Jul 2019	malignant pancreatic neoplasm	Brown University	Completed	No outcome recorded
Phase 2	NCT02073487	Feb 2014 → Jan 2019	breast cancer	The Methodist Hospital Research Institute	Completed	Met primary
Phase 2	NCT01963325	Aug 2013 → Dec 2017	cholangiocarcinoma	Yuhong Li	Completed	No outcome recorded
Phase 2	NCT01839799	Apr 2013 → Apr 2017	pancreatic adenocarcinoma	Abramson Cancer Center at Penn Medicine	Completed	No outcome recorded
Phase 2	NCT01730586	Nov 2012 → Aug 2016	colorectal cancer	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 2	NCT01446016	Sep 2011 → Mar 2019	breast cancer	The Methodist Hospital Research Institute	Completed	No outcome recorded
Phase 2	NCT01307891	Mar 2011 → Jun 2016	triple-negative breast carcinoma	University of Alabama at Birmingham	Completed	No outcome recorded
Phase 2	NCT01821859	Jan 2010 → Nov 2011	ovarian cancer, peritoneum cancer	OHSU Knight Cancer Institute	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00723125	Sep 2008 → May 2014	breast cancer	William Sikov MD	Completed	No outcome recorded
Phase 2	NCT00691054	Jun 2008 → Dec 2012	malignant pancreatic neoplasm	University of Miami	Completed	Met primary
Phase 2	NCT00625573	Sep 2007 → Feb 2009	colorectal cancer	Mt. Sinai Medical Center, Miami	Completed	No outcome recorded
Phase 2	NCT00521781	Aug 2007 → Sep 2008	prostate neoplasm	The Methodist Hospital Research Institute	Terminated	No outcome recorded Stop: Business
Phase 2	NCT00503906	Jun 2007 → Mar 2011	breast cancer	University of Miami	Completed	No outcome recorded
Phase 2	NCT00472693	May 2007 → Apr 2011	breast cancer	Abramson Cancer Center at Penn Medicine	Completed	No outcome recorded
Phase 2	NCT00462423	Apr 2007 → Apr 2011	metastatic melanoma	Lynn E. Spitler, MD	Completed	No outcome recorded
Phase 2	NCT00407563	Jan 2007 → Feb 2011	malignant epithelial tumor of ovary, primary peritoneal carcinoma	Accelerated Community Oncology Research Network	Completed	No outcome recorded
Phase 2	NCT00466986	Nov 2005 → Oct 2011	fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma	Southeastern Gynecologic Oncology	Completed	No outcome recorded

Phase 32 trials · 1 missed
Phase 3	NCT02027428	Feb 2014 → Sep 2017	non-small cell squamous lung carcinoma	Celgene Corporation	Completed	Missed primary
Phase 3	NCT01822314	Apr 2013 → Sep 2016	female breast carcinoma	Fondazione Michelangelo	Completed	No outcome recorded
Phase not applicable2 trials
—	NCT03647514	Dec 2018 → Sep 2020	breast cancer	Zhejiang Cancer Hospital	Unknown	No outcome recorded
—	NCT03647280	Dec 2018 → Sep 2020	breast cancer	Zhejiang Cancer Hospital	Unknown	No outcome recorded
Comparator or background therapy27 trials
Phase 0	NCT06326736 Background	Apr 2024 → Dec 2025 overdue	malignant pancreatic neoplasm	Jinling Hospital, China	Recruiting	No outcome recorded
Phase 0	NCT05438797 Background	Apr 2021 → Apr 2024	digestive system cancer	Sizhen Wang	Unknown	No outcome recorded
Phase 1	NCT05631886 Background	Jul 2023 → Dec 2025 overdue	cancer, lymphoma	Chinese PLA General Hospital	Recruiting	No outcome recorded
Phase 1	NCT05631899 Background	Apr 2023 → Jun 2026 overdue	cancer	Chinese PLA General Hospital	Active not recruiting	No outcome recorded
Phase 1	NCT02873598 Background	Nov 2016 → Jun 2019	malignant pancreatic neoplasm	University of Colorado, Denver	Completed	No outcome recorded
Phase 1	NCT02030860 Background	Jan 2014 → Dec 2015	pancreatic adenocarcinoma	Abramson Cancer Center at Penn Medicine	Completed	No outcome recorded
Phase 1	NCT02045589 Background	Jan 2014 → Oct 2016	pancreatic adenocarcinoma	Theriva Biologics SL	Completed	No outcome recorded
Phase 1	NCT00337376 Background	Feb 2006 → Jul 2010	—	Yale University	Terminated	No outcome recorded
Phase 1/2	NCT03361319 Background	Jul 2020 → Jul 2023	lung adenocarcinoma	Royal Marsden NHS Foundation Trust	Withdrawn	No outcome recorded Stop: Business
Phase 1/2	NCT04068896 Background	Oct 2019 → Sep 2023	colorectal cancer, esophageal cancer, gastric cancer, head and neck squamous cell carcinoma +6	NGM Biopharmaceuticals, Inc	Completed	No outcome recorded
Phase 1/2	NCT03950570 Background	May 2019 → Jan 2023	metastatic neoplasm	Orinove, Inc.	Completed	No outcome recorded
Phase 1/2	NCT03189914 Background	Oct 2017 → Oct 2019	malignant pancreatic neoplasm	Processa Pharmaceuticals	Completed	No outcome recorded
Phase 1/2	NCT01506973 Background	Dec 2011 → Mar 2022	adenocarcinoma	Abramson Cancer Center at Penn Medicine	Completed	Missed primary
Phase 2	NCT06745882 Background	Jun 2025 → Jan 2030 expected	non-small cell lung carcinoma	H. Lee Moffitt Cancer Center and Research Institute	Recruiting	No outcome recorded
Phase 2	NCT07394387 Background	Jan 2025 → Jun 2026 overdue	triple-negative breast carcinoma	The First Affiliated Hospital with Nanjing Medical University	Recruiting	No outcome recorded
Phase 2	NCT04589234 Background	Oct 2020 → Dec 2030 expected	malignant pancreatic neoplasm	Salspera LLC	Active not recruiting	No outcome recorded
Phase 2	NCT04590625 Background	Oct 2020 → Oct 2022	ovarian carcinoma	Zhongshan Hospital Xiamen University	Unknown	No outcome recorded
Phase 2	NCT04134468 Background	Jan 2020 → Feb 2021	pancreatic ductal adenocarcinoma	Abramson Cancer Center at Penn Medicine	Withdrawn	No outcome recorded
Phase 2	NCT02662634 Background	Mar 2016 → Mar 2018	non-small cell lung carcinoma	GU Research Network, LLC	Withdrawn	No outcome recorded
Phase 2	NCT02289898 Background	Apr 2015 → May 2017	pancreatic ductal adenocarcinoma	OncoMed Pharmaceuticals, Inc.	Completed	Missed primary
Phase 2	NCT02080221 Background	Aug 2014 → Jan 2020	malignant pancreatic neoplasm	Brown University	Completed	No outcome recorded
Phase 2	NCT01933061 Background	Jan 2014	metastatic melanoma	Celgene Corporation	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT01978184 Background	Nov 2013 → Feb 2018	malignant pancreatic neoplasm	Nathan Bahary, MD	Completed	No outcome recorded
Phase 2	NCT02067416 Comparator	Jul 2012 → Jun 2014	breast cancer	Jenny C. Chang, MD	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT00736944 Background	Dec 2008 → Aug 2010	head and neck squamous cell carcinoma	Washington University School of Medicine	Completed	No outcome recorded
Phase 3	NCT03164616 Background	Jun 2017 → Mar 2021 overdue	non-small cell lung carcinoma	AstraZeneca	Active not recruiting	No outcome recorded
Phase 3	NCT02620280 Background	Apr 2016 → Jan 2024	invasive ductal breast carcinoma	Fondazione Michelangelo	Completed	No outcome recorded

Press releases naming this drug 12 releases

Date	Issuer	Release
2020-06-17	Genentech, Inc.	Genentech’s Tecentriq in Combination With Chemotherapy (Including Abraxane) Meets Primary Endpoint of Improved Pathological Complete Response, Regardless of PD-L1 Status, as Initial Treatment for People With Early Triple-negative Breast Cancer gene.com ↗
2019-12-03	Genentech, Inc.	FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer gene.com ↗
2019-03-08	Genentech, Inc.	FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer gene.com ↗
2019-01-16	Genentech, Inc.	FDA Accepts Genentech’s Supplemental Biologics License Application for Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer gene.com ↗
2018-11-12	Genentech, Inc.	FDA Grants Priority Review to Genentech’s Tecentriq in Combination With Abraxane for the Initial Treatment of People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer gene.com ↗
2018-10-22	Genentech, Inc.	Genentech’s Tecentriq Plus Chemotherapy (Carboplatin and Abraxane) as an Initial Treatment Helped People With Advanced Non-Squamous Non-Small Cell Lung Cancer Live Significantly Longer Compared to Chemotherapy Alone gene.com ↗
2018-10-20	Genentech, Inc.	Genentech’s Tecentriq in Combination With Abraxane Improves Outcomes as an Initial Treatment for People With PD-L1-Positive Metastatic Triple-Negative Breast Cancer gene.com ↗
2018-07-01	Genentech, Inc.	Phase III IMpassion130 Study Showed Genentech's TECENTRIQ Plus Abraxane Significantly Reduced the Risk of Disease Worsening or Death in People With Metastatic or Locally Advanced Triple Negative Breast Cancer gene.com ↗
2018-06-02	Genentech, Inc.	Phase III IMpower131 Study Showed Genentech’s TECENTRIQ (Atezolizumab) Plus Chemotherapy (Carboplatin And ABRAXANE) Reduced the Risk of Disease Worsening or Death for People With Advanced Squamous Non-Small Cell Lung Cancer gene.com ↗
2018-05-28	Genentech, Inc.	Phase III IMpower130 Study Showed Genentech’s TECENTRIQ (Atezolizumab) Plus Chemotherapy (Carboplatin and ABRAXANE) Helped People With Metastatic Non-Squamous Non-Small Cell Lung Cancer Live Significantly Longer Compared to Chemotherapy Alone gene.com ↗
2018-03-19	Genentech, Inc.	Phase III IMpower131 Study Showed Genentech’s TECENTRIQ (Atezolizumab) Plus Chemotherapy (Carboplatin and ABRAXANE) Reduced The Risk of Disease Worsening or Death in the Initial Treatment of People With a Type of Advanced Squamous Lung Cancer gene.com ↗
2016-03-16	Halozyme Therapeutics	Halozyme Doses First Patient In Phase 3 Clinical Trial Of PEGPH20 In Combination With ABRAXANE® And Gemcitabine halozyme.com ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 76 sources stand behind the page.

Field	Value	Cited text
Known as	ABRAXANE	“The aim of this phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with...” NCT03158779 ↗ 77 “Patients will receive gemcitabine at 1000 mg/m2 and abraxane at 125 mg/m2 intravenously on days 1, 8 and 15 of a 28 day cycle for 2 cycles” NCT01783054 ↗ “Abraxane will be administered at a fixed dose of 100 mg/m2 as an IV infusion weekly for three weeks in a row followed by one week of rest” NCT02142335 ↗ “physician choice: taxane-based chemotherapy to include Paclitaxel, Docetaxel, Abraxane or Ixabepilone given as standard of care” NCT02067416 ↗ “abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1” NCT04590625 ↗ “Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.” NCT02578732 ↗ “Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.” NCT02080221 ↗ “Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.” NCT02022033 ↗ “RX-3117 will be administered orally in combination with Abraxane.” NCT03189914 ↗ “ABRAXANE® 75 mg/m2 over 30 min Days 5 and 12” NCT02581501 ↗ “Abraxane:100-200 mg/m2，QD×1D” NCT05438797 ↗ Show 67 more sources
Known as	ABI-007	“This study uses the drugs Abraxane (also called ABI-007) and Vandetanib (also called Zactima and ZD6474).” NCT00667147 ↗ 1 “Bevacizumab and ABI-007 (Abraxane)” NCT00472693 ↗
Known as	Abraxane, also ABI-007	“Abraxane, also ABI-007” NCT01307891 ↗
Action	Inhibit	“albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.” NCT02073487 ↗
Modality	Small molecule	“Abraxane is a taxane” NCT00462423 ↗
Route	Intravenous	“intravenous administration of 100mg/m2 Abraxane over 30 minutes” NCT00337376 ↗