Oraxol (oral paclitaxel/encequidar) / Athenex 
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 0 Diseases   4 Trials   4 Trials   235 News 


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  • ||||||||||  Genomic Landscape and Clinical Outcomes of Triple-Negative Invasive Lobular Carcinoma (Hall 2-3) -  Nov 4, 2023 - Abstract #SABCS2023SABCS_1756;    
    Currently the management of TN ILC is extrapolated from that of TN IDC, however our patients did not respond to chemoimmunotherapy. The presence of HER2-low status or somatic ERBB2 mutations may provide opportunities for treatment with an anti-HER2 antibody-drug conjugate or tyrosine kinase inhibitor.
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion date, Trial termination:  The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol (clinicaltrials.gov) -  May 22, 2023   
    P1,  N=29, Terminated, 
    ClinicalTrials.gov Identifier: NCT03165955. Trial completion date: Oct 2023 --> May 2023 | Recruiting --> Terminated; STUDY HALTED DUE TO FINANCIAL CONTRAINTS
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Metastases:  KEYNOTE-E06: Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  May 19, 2023   
    P1,  N=34, Terminated, 
    Trial completion date: Oct 2023 --> May 2023 | Recruiting --> Terminated; STUDY HALTED DUE TO FINANCIAL CONTRAINTS N=86 --> 34 | Trial completion date: Oct 2024 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Sep 2024 --> May 2023; Study terminated due to lack of funding
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion, Trial completion date, Trial primary completion date:  KX-ORAX-010t: A Study of Oraxol in Subjects With Cutaneous Angiosarcoma (clinicaltrials.gov) -  May 19, 2023   
    P2,  N=48, Completed, 
    N=86 --> 34 | Trial completion date: Oct 2024 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Sep 2024 --> May 2023; Study terminated due to lack of funding Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> May 2023 | Trial primary completion date: Sep 2023 --> May 2023
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  KEYNOTE-E06: Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  May 10, 2023   
    P1,  N=86, Recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> May 2023 | Trial primary completion date: Sep 2023 --> May 2023 Trial completion date: Jun 2023 --> Oct 2024 | Trial primary completion date: Mar 2023 --> Sep 2024
  • ||||||||||  Herceptin (trastuzumab) / Roche, Jemperli (dostarlimab-gxly) / GSK
    Oral paclitaxel and dostarlimab with or without trastuzumab in early-stage, high-risk breast cancer: Results from the neoadjuvant ISPY 2 TRIAL. (Available On Demand; Poster Bd # 442) -  Apr 26, 2023 - Abstract #ASCO2023ASCO_1000;    
    P2
    In the HR+ signature where we would not expect a benefit of D, we see equal response to OPE with decreased rates of peripheral neuropathy and alopecia, which suggest this oral agent may be an attractive alternative to IV P in this subgroup and is under consideration in ISPY 2.2. We did not observe the expected improvement in pCR rates seen with PD-1 inhibitors in the HR- or MP2 subtypes (over P alone historic control).
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion date, Trial primary completion date:  KX-ORAX-010t: A Study of Oraxol in Subjects With Cutaneous Angiosarcoma (clinicaltrials.gov) -  Feb 1, 2023   
    P2,  N=43, Active, not recruiting, 
    We did not observe the expected improvement in pCR rates seen with PD-1 inhibitors in the HR- or MP2 subtypes (over P alone historic control). Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Sep 2022 --> Sep 2023
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion date, Trial primary completion date:  KX-ORAX-010t: A Study of Oraxol in Subjects With Cutaneous Angiosarcoma (clinicaltrials.gov) -  Aug 1, 2022   
    P2,  N=43, Active, not recruiting, 
    Active, not recruiting --> Completed Trial completion date: Apr 2022 --> Sep 2022 | Trial primary completion date: Apr 2022 --> Sep 2022
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    P1 data, Clinical Trial,Phase I, Journal:  A phase Ib study of Oraxol (oral paclitaxel and encequidar) in patients with advanced malignancies. (Pubmed Central) -  Jul 24, 2022   
    Trial completion date: Apr 2022 --> Sep 2022 | Trial primary completion date: Apr 2022 --> Sep 2022 The oral administration of encequidar with paclitaxel was safe, achieved clinically relevant paclitaxel levels, and showed evidence of anti-tumor activity.
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    PK/PD data, Journal:  Population Pharmacokinetics for Oral Paclitaxel in Patients with Advanced/Metastatic Solid Tumors. (Pubmed Central) -  Jul 23, 2022   
    Oraxol consists of an oral dosage form of the chemotherapeutic agent paclitaxel administered with a novel P-glycoprotein inhibitor encequidar methanesulfonate monohydrate (formerly named HM30181A), which allows oral treatment of cancers that would otherwise be treated with intravenous paclitaxel...Age, sex, body weight or surface area, mild hepatic impairment, and mild to moderate renal impairment had no clinically meaningful effects on the systemic exposure of oral paclitaxel. Simulations were performed on clinical therapeutic dose [Oral paclitaxel 205 mg/m once daily (QD) x 3 days per week] to predict exposure of oral paclitaxel, and to support treatment benefits observed in a pivotal Phase 3 trial.
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    A novel oral paclitaxel and HM10381 (oraxel)-treated metastatic breast cancer: A phase I study (KX‑ORAX‑CN-007). (Available On Demand; 481) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_1190;    
    P1
    Simulations were performed on clinical therapeutic dose [Oral paclitaxel 205 mg/m once daily (QD) x 3 days per week] to predict exposure of oral paclitaxel, and to support treatment benefits observed in a pivotal Phase 3 trial. The study showed that Oraxol as novel oral chemotherapy agent shows promising antitumor activity in patients with metastatic breast cancer, manageable toxicity, and no hypersensitivity-type reactions.
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Enrollment change, Trial termination:  An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007 (clinicaltrials.gov) -  Mar 3, 2022   
    P1,  N=11, Terminated, 
    With further study, oPac+E could be an alternative to IVP. N=24 --> 11 | Recruiting --> Terminated; No need to complete the overall survival (OS) follow-up as the sample size was too small to interpret OS.
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion date, Trial primary completion date:  The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol (clinicaltrials.gov) -  Feb 16, 2022   
    P1,  N=36, Recruiting, 
    N=24 --> 11 | Recruiting --> Terminated; No need to complete the overall survival (OS) follow-up as the sample size was too small to interpret OS. Trial completion date: May 2022 --> Oct 2022 | Trial primary completion date: Jan 2022 --> Jul 2022
  • ||||||||||  paclitaxel / Generic mfg.
    Journal:  Cost of home vs clinic administration of paclitaxel in metastatic breast cancer. (Pubmed Central) -  Sep 26, 2021   
    (NCT 02594371) Home administration of oral paclitaxel and encequidar was associated with lower administration costs compared with once-every-3-weeks IV paclitaxel (175 mg/m2) and protein-bound paclitaxel, resulting in potential cost savings for payers.
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion, Trial completion date, Trial primary completion date, Metastases:  A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies (clinicaltrials.gov) -  Sep 13, 2021   
    P1,  N=38, Completed, 
    Home administration of oral paclitaxel and encequidar was associated with lower administration costs compared with once-every-3-weeks IV paclitaxel (175 mg/m2) and protein-bound paclitaxel, resulting in potential cost savings for payers. Recruiting --> Completed | Trial completion date: Nov 2020 --> May 2021 | Trial primary completion date: Jun 2020 --> Mar 2021
  • ||||||||||  Biomarker, Trial completion date, Trial primary completion date:  I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) -  Aug 27, 2021   
    P2,  N=4000, Recruiting, 
    Recruiting --> Completed | Trial completion date: Nov 2020 --> May 2021 | Trial primary completion date: Jun 2020 --> Mar 2021 Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion, Trial completion date, Trial primary completion date:  A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients (clinicaltrials.gov) -  Jul 29, 2021   
    P2,  N=44, Completed, 
    Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Jun 2021 | Trial primary completion date: Dec 2021 --> Jun 2021
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion date, Trial primary completion date:  A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients (clinicaltrials.gov) -  May 11, 2021   
    P2,  N=44, Active, not recruiting, 
    Encouraging anti-tumor activity was observed and phase 2 studies evaluating the combination are being planned. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion date, Combination therapy:  Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers (clinicaltrials.gov) -  Mar 18, 2021   
    P1b,  N=36, Active, not recruiting, 
    Patients with HR+/HER2-, TNBC, and Unknown subtypes responded considerably better to oPac+E vs IVPac—especially the HR+/HER2- subtype which represented 63% of the patients treated with oPac+E and 55% of the patients treated with IVPac. Trial completion date: Mar 2021 --> Jul 2021
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Phase classification, Trial completion date, Trial primary completion date:  KX-ORAX-010t: A Study of Oraxol in Subjects With Cutaneous Angiosarcoma (clinicaltrials.gov) -  Feb 4, 2021   
    P2,  N=43, Recruiting, 
    Phase classification: P1 --> P2 Phase classification: P1 --> P2 | Trial completion date: Dec 2020 --> Apr 2022 | Trial primary completion date: Dec 2020 --> Apr 2022
  • ||||||||||  Oraxol (oral paclitaxel/encequidar) / Athenex
    Trial completion date, Trial primary completion date, Combination therapy, Metastases:  KEYNOTE-E06: Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) -  Jan 8, 2021   
    P1,  N=114, Recruiting, 
    Phase classification: P1 --> P2 | Trial completion date: Dec 2020 --> Apr 2022 | Trial primary completion date: Dec 2020 --> Apr 2022 Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Oct 2020 --> Mar 2023