Table 2.
Phase III/IV clinical trials of albumin-bound paclitaxel (nab-P)
| ClinicalTrials.gov identifier | Trial description | Treatment | Primary endpoint | Planned enrollment | Planned primary completion |
|---|---|---|---|---|---|
| BC | |||||
| NCT0188123048 | Phase II/III tnAcity trial: evaluate risk/benefit of nab-P in combination with gem and carbo compared with gem and carbo in metastatic TNBC | Nab-P 125 mg/m2 + gem 1,000 mg/m2 qw 2/3 vs nab-P 125 mg/m2 + carbo AUC 2 qw 2/3 vs gem 1,000 mg/m2 + carbo AUC 2 qw 2/3 | PFS | 790 | October 2015 |
| NCT0178133849,50 | Phase II/III ADAPT trial: adjuvant dynamic marker- adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer | Nab-P 125 mg/m2 qw or sb-pac 175 mg/m2 q2w; both in combination with epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 q2w for 8 weeks | Identification of a responder subpopulation within intermediate- and high-risk groups in any BC subtype, which due to therapy has a comparable outcome to a low-risk group | 4,936 | April 2020 |
| NCT0182231451 | Phase III ETNA trial: neoadjuvant chemotherapy with nab-P in women with HER2-negative high-risk BC | Nab-p 125 mg/m2 qw 3/4×4 cycles vs sb-P 90 mg/mg2 qw 3/4×4 cycles; both followed by AC or EC or FEC q3w | pCR | 632 | September 2016 |
| NCT0169070252 | Phase III GAIN-2 trial: study of nab-P in high-risk early BC | EC + nab-Pa 260–330 mg/mg2 q2w vs EC + docetaxel | DFS | 2,886 | January 2016 |
| NCT0201927753 | Phase III trial: study of pertuzumab and trastuzumab in combination with a taxane in patients with advanced HER2-positive BC | Pertuzumab, trastuzumab, and taxane (investigators’ choice of docetaxel, paclitaxel, or nab-P) | Safety | 50 | May 2017 |
| NCT0157203854 | Phase III PERUSE trial: study of pertuzumab in combination with trastuzumab and a taxane in first-line treatment in patients with HER2-positive advanced BC | Pertuzumab, trastuzumab, and taxane (investigators’ choice of docetaxel, paclitaxel, or nab-P) | Safety | 1,500 | May 2018 |
| NSCLC | |||||
| NCT0215114963 | Phase IV ABOUND.70+ trial: safety and efficacy study of nab-P in combination with carbo to treat advanced NSCLC in the elderly | Nab-P 100 mg/m2 + carbo AUC 6 q3w vs nab-P 100 mg/m2 + carbo AUC 6 q4w | Incidence of peripheral neuropathy and myelosuppression | 284 | December 2016 |
| NCT0202742866 | Phase III ABOUND.sqm trial: safety and efficacy study of nab-P as maintenance therapy after nab-P plus carbo in first-line stage IIIB/IV squamous-cell NSCLC | Induction: nab-P 100 mg/m2 qw + carbo AUC 6 q3w ×4 cycles Maintenance: nab-P 100 mg/m2 qw 2/3 or best supportive care | PFS | 260 | May 2016 |
| PC | |||||
| NCT0196443070 | Phase III APACT trial: nab-P and gem vs gem alone as adjuvant therapy for patients with resected PC | Nab-P 125 mg/m2 + gem 1,000 mg/m2 qw 3/4 vs gem 1,000 mg/m2 qw 3/4 | DFS | 800 | April 2019 |
| NCT0183643271 | Phase III PILLAR: immunotherapy study in borderline resectable or locally advanced unresectable PC | FOLFIRINOX or nab-P 125 mg/m2 + gem 1,000 mg/m2 qw 3/4 with or without algenpantucel-L immunotherapy | OS | 280 | September 2015 |
Note:
Nab-P dose to be determined in a run-in phase.
Abbreviations: ABOUND.70+, Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly (70+); ABOUND.sqm, Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB/IV Squamous Cell Non-small Cell Lung Cancer (abound); AC, doxorubicin and cyclophosphamide; ADAPT, Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial; APACT, Adjuvant Pancreatic Adenocarcinoma Clinical Trial; AUC, area under the concentration-time curve; BC, breast cancer; carbo, carboplatin; DFS, disease-free survival; EC, epirubicin and cyclophosphamide; FEC, 5-fluorouracil, epirubicin, and cyclophosphamide; FOLFIRINOX, leucovorin, 5-fluorouracil, irinotecan, oxaliplatin; gem, gemcitabine; HER2, human epidermal growth factor receptor 2; NSCLC, non-small-cell lung cancer; OS, overall survival; PC, pancreatic cancer; pCR, pathologic complete response; PERUSE, Phase III trial of pertuzumab in combination with trastuzumab and a taxane in first-line treatment in patients with HER2-positive advanced BC; PFS, progression-free survival; Phase PILLAR, Immunotherapy Study in Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer; qw 2/3, first 2 of 3 weeks; qw 3/4, first 3 of 4 weeks; qw, weekly; q2w, every 2 weeks; q3w, every 3 weeks; q4w, every 4 weeks; sb-P, solvent-based paclitaxel; tnAcity, Triple-Negative Albumin-Bound Paclitaxel Combination International Treatment Study; TNBC, triple-negative breast cancer.