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Last Updated: July 5, 2020

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CLINICAL TRIALS PROFILE FOR ABRAXANE

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505(b)(2) Clinical Trials for ABRAXANE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01583426 Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto) Active, not recruiting Celgene Corporation Phase 3 2012-07-01 Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.
New Formulation NCT01583426 Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto) Active, not recruiting Roche Pharma AG Phase 3 2012-07-01 Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.
New Formulation NCT01583426 Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto) Active, not recruiting German Breast Group Phase 3 2012-07-01 Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for ABRAXANE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00093145 Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer Completed Celgene Corporation Phase 2 2004-06-01 This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.
NCT00107094 Study of Adriamycin Plus Cyclophosphamide Followed by Abraxane as Adjuvant Therapy for Patients With Breast Cancer Completed Celgene Corporation Phase 1 2005-03-01 In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage breast cancer.
NCT00110084 ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer Completed National Cancer Institute (NCI) Phase 2 2005-08-01 RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ABRAXANE

Condition Name

Condition Name for ABRAXANE
Intervention Trials
Breast Cancer 49
Pancreatic Cancer 34
Pancreatic Adenocarcinoma 20
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Condition MeSH

Condition MeSH for ABRAXANE
Intervention Trials
Pancreatic Neoplasms 97
Breast Neoplasms 88
Adenocarcinoma 70
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Clinical Trial Locations for ABRAXANE

Trials by Country

Trials by Country for ABRAXANE
Location Trials
United States 969
Italy 69
Australia 44
Spain 42
Canada 40
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Trials by US State

Trials by US State for ABRAXANE
Location Trials
Texas 62
California 54
Pennsylvania 48
New York 46
Florida 44
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Clinical Trial Progress for ABRAXANE

Clinical Trial Phase

Clinical Trial Phase for ABRAXANE
Clinical Trial Phase Trials
Phase 4 2
Phase 3 19
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for ABRAXANE
Clinical Trial Phase Trials
Recruiting 106
Completed 69
Not yet recruiting 57
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Clinical Trial Sponsors for ABRAXANE

Sponsor Name

Sponsor Name for ABRAXANE
Sponsor Trials
Celgene Corporation 96
National Cancer Institute (NCI) 43
Celgene 20
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Sponsor Type

Sponsor Type for ABRAXANE
Sponsor Trials
Other 330
Industry 221
NIH 44
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