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Poster Display session 1

6144 - An international randomized cross-over bio-equivalence study of oral paclitaxel + HM30181 compared with weekly intravenous (IV) paclitaxel in patients with advanced solid tumors

Date

28 Sep 2019

Session

Poster Display session 1

Presenters

Christopher Jackson

Citation

Annals of Oncology (2019) 30 (suppl_5): v159-v193. 10.1093/annonc/mdz244

Authors

C.G.C.A. Jackson1, S. Deva2, K. Bayston3, B. McLaren4, P. Barlow2, N.A. Hung5, K. Clarke6, E. Segelov7, T. Chao8, M. Dai9, H. Yen10, E. Ang2, D. Cutler11, D. Kramer11, J. Zhi11, W. Chan11, M.R. Kwan11, C. Hung12

Author affiliations

  • 1 Department Of Medicine, University of Otago, 9016 - Dunedin/NZ
  • 2 Blood And Cancer, Auckland District Health Board, Auckand/NZ
  • 3 Southern Blood And Cancer, Southern DHB, Invercargill/NZ
  • 4 Southern Blood And Cancer, Southern DHB, Dunedin/NZ
  • 5 University Of Otago, University of Otago, Dunedin/NZ
  • 6 Wellington Blood And Cancer, Capital and Coast DHB, Wellington/NZ
  • 7 Monash Health, Monash University, 3168 - Clayton/AU
  • 8 Division Of Hematology And Oncology, Shuang-Ho Hospital, 23561 - New Taipei City/TW
  • 9 Haematology And Oncology, Tri-Service General Hospital, Taiwan/TW
  • 10 General Surgery, Lotung Poh-Ai Hospital, Taiwan/TW
  • 11 Athenex Inc, Athenex Inc, Buffalo/US
  • 12 Zenith Technology Corporation Limited, Zenith Technology Corporation Limited, Dunedin/NZ
More

Resources

Abstract 6144

Background

Paclitaxel has poor oral bioavailability due to excretion by P-glycoprotein (P-gp) on intestinal cells. Oral paclitaxel may reduce IV access, avoid risks of allergic reaction to cremophor, forego steroid premedication, reduce hospital stay, and improve patient convenience. Oraxol (Athenex, USA) is a combination of oral paclitaxel and HM30181, a novel orally active, potent and specific inhibitor of P-gp with minimal or undetectable systemic exposure. We report the results of a bio-equivalence study of Oraxol compared to IV paclitaxel.

Methods

An international randomized crossover pharmacokinetic (PK) study using HM30181 15mg plus oral paclitaxel 205mg/m2 was given on days 1-3 and compared to a single dose of IV paclitaxel (80 mg/m2) in patients with advanced solid tumors. PK blood samples were taken days 1-9 for oral paclitaxel and days 1-5 for IV paclitaxel.

Results

44 patients were randomized. 35 patients were evaluable. The first cohort included 6 patients as a feasibility study. The second cohort included 29 patients and showed:Table:

477P

Oraxol 205mg/m2 days 1-3Paclitaxel 80mg/m2 IV
AUC0-∞ (hr*ng/mL)5001.185589.70
Cmax (ng/mL)366.39 (0-24 hr), 324.26 (24-48 hr), 296.10 (48-72 hr)2710.48
AUC0-t4797.085425.59
GMR (%, 90% CI)89.10 (83.53, 95.03)
Intra-subject CV (%)16.05

Conclusions

Oraxol (oral paclitaxel + HM30181) given daily for 3 days can show bio-equivalence to single dose of IV paclitaxel 80mg/m2 at 80% power with 90% CI of the GMR within the limits of 80 – 125%.

Clinical trial identification

ACTRN 12615000894594.

Editorial acknowledgement

Legal entity responsible for the study

Athenex.

Funding

Athenex.

Disclosure

C.G.C.A. Jackson: Travel / Accommodation / Expenses: Athenex. N.A. Hung: Shareholder / Stockholder / Stock options, Full / Part-time employment: Zentech. D. Cutler: Shareholder / Stockholder / Stock options, Full / Part-time employment: Athenex. D. Kramer: Full / Part-time employment: Athenex. J. Zhi: Full / Part-time employment: Athenex. W. Chan: Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: Athenex. M.R. Kwan: Leadership role, Travel / Accommodation / Expenses, Full / Part-time employment: Athenex. C. Hung: Research grant / Funding (self), Shareholder / Stockholder / Stock options, Patent: Athenex; Shareholder / Stockholder / Stock options: Zentech. All other authors have declared no conflicts of interest.

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