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- | Biomarker, Phase classification, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Oct 14, 2020
P1, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Phase classification: P2 --> P1
- Oraxol (oral paclitaxel/encequidar) / Athenex
[VIRTUAL] Oral Paclitaxel and Encequidar (oPac+E) versus IV paclitaxel (IVPac) in the treatment of metastatic breast cancer (mBC) patients (Study KX-ORAX-001): Progression Free Survival (PFS) and Overall Survival (OS) updates (Channel 1) - Oct 2, 2020 - Abstract #SABCS2020SABCS_1163;
Updated data for duration of response, PFS and OS for the ITT and prespecified mITT populations will be presented. (NCT 02594371)
- Oraxol (oral paclitaxel/encequidar) / Athenex
[VIRTUAL] Oral paclitaxel and encequidar (oPac+E) in the treatment of metastatic breast cancer (mBC): Management of gastrointestinal adverse events (GI AE). Study KX-ORAX-001 (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_815;
GI AE in oPac+E treated patients can be managed by prophylactic use of anti-emetics, primarily 5-HT 3 inhibitors and early intervention with the anti-diarrhea agent loperamide. The use of the oral NK1 inhibitor aprepitant in combination with oPac+E is not recommended.(NTC02594371)
- Oraxol (oral paclitaxel/encequidar) / Athenex
[VIRTUAL] Lower rates of neuropathy with oral paclitaxel and encequidar (oPac+E) compared to IV paclitaxel (IVPac) in treatment of metastatic breast cancer (mBC): Study KX-ORAX-001 (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_810;
Fewer patients receiving oPac+E required dose reduction due to neuropathy and no patients receiving oPac+E discontinued treatment due to neuropathy. Reduction in neuropathy may improve quality of life and allow longer administration of effective therapy while maintaining dose intensity.
- Oraxol (oral paclitaxel/encequidar) / Athenex
[VIRTUAL] A phase 2 study of oral paclitaxel and encequidar (oPac+E) in the treatment of cutnaeous angiosarcoma: The breast angiosarcoma subgroup (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_809;
It is generally well tolerated even in elderly patients; with low incidence of neuropathy. It may allow patients to avoid hospital IV chemotherapy visits and the option of home treatment.
- || Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment change, Trial primary completion date: KX-ORAX-010t: A Study of Oraxol in Subjects With Cutaneous Angiosarcoma (clinicaltrials.gov) - Aug 13, 2020
P1, N=43, Recruiting, Sponsor: Athenex, Inc.
It may allow patients to avoid hospital IV chemotherapy visits and the option of home treatment. N=25 --> 43 | Trial primary completion date: Aug 2020 --> Dec 2020
- || Oraxol (oral paclitaxel/encequidar) / Athenex
Trial completion: KX-ORAX-007: A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients (clinicaltrials.gov) - Jul 8, 2020
P1, N=28, Completed, Sponsor: Athenex, Inc.
N=25 --> 43 | Trial primary completion date: Aug 2020 --> Dec 2020 Recruiting --> Completed
- ||||| Oraxol (oral paclitaxel/encequidar) / Athenex
Clinical: Oraxol + Encequidar in Angiosarcoma: Response rate of 50%, Stable disease 50%. This investigator initiated study that started at MD Anderson is now open globally. A big thank you to OUR PATIENTS, investigators and Sarcoma team! https://t.co/Fp9DxReRCH (Twitter) - May 30, 2020
- |||| Oraxol (oral paclitaxel/encequidar) / Athenex
#asco20 abstr 11517 #oraxol oral paclitaxel + encequidar in cutaneous non-metastatic #angiosarcoma ORR 50% and CBR 100%. @vinodravi @herbloong #sarcoma (Twitter) - May 29, 2020
- || Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers (clinicaltrials.gov) - May 18, 2020
P1b, N=36, Active, not recruiting, Sponsor: Athenex, Inc.
Recruiting --> Completed Recruiting --> Active, not recruiting | N=18 --> 36 | Trial completion date: Dec 2019 --> Mar 2021 | Trial primary completion date: Dec 2019 --> Dec 2020
- Oraxol (oral paclitaxel/encequidar) / Athenex
[VIRTUAL] A phase II study of oraxol in the treatment of unresectable cutaneous angiosarcoma. (Poster Board 405) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2538;
P1
It is generally well tolerated even in an older patient population; particularly with respect to the the low incidence of neuropathy compared to IV paclitaxel. Recruitment is ongoing.
- | Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment closed, Trial completion date, Trial primary completion date: A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients (clinicaltrials.gov) - Apr 23, 2020
P2, N=44, Active, not recruiting, Sponsor: Athenex, Inc.
Recruitment is ongoing. Recruiting --> Active, not recruiting | Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020
- | Oraxol (oral paclitaxel/encequidar) / Athenex
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) - Mar 27, 2020
P1, N=30, Recruiting, Sponsor: Athenex, Inc.
Recruiting --> Active, not recruiting | Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020 Trial completion date: Mar 2020 --> Nov 2020 | Trial primary completion date: Sep 2019 --> Jun 2020
- ||| Oraxol (oral paclitaxel/encequidar) / Athenex
Trial completion date, Metastases: KX-ORAX-001: Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer (clinicaltrials.gov) - Mar 27, 2020
P3, N=402, Active, not recruiting, Sponsor: Athenex, Inc.
Trial completion date: Mar 2020 --> Nov 2020 | Trial primary completion date: Sep 2019 --> Jun 2020 Trial completion date: Nov 2019 --> Jul 2020
- || Oraxol (oral paclitaxel/encequidar) / Athenex
Trial initiation date: The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol (clinicaltrials.gov) - Feb 18, 2020
P1, N=36, Recruiting, Sponsor: Athenex, Inc.
Trial completion date: Nov 2019 --> Jul 2020 Initiation date: Mar 2019 --> Aug 2019
- | Biomarker, Enrollment change, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Feb 10, 2020
P2, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Initiation date: Mar 2019 --> Aug 2019 N=1920 --> 4000
- | Biomarker, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Jan 22, 2020
P2, N=1920, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
N=1920 --> 4000 Trial primary completion date: Dec 2020 --> Dec 2025
- || Oraxol (oral paclitaxel/encequidar) / Athenex, [fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca, margetuximab (MGAH 22) / MacroGenics
#SABCS2019 is fast approaching with Senior Reporter @ManasiVaidya22 attending. $ATNX's Oraxol, $MGNX's margetuximab, and $DSKYF's DS-8201 are expected to steal the limelight!! (Twitter) - Dec 2, 2019
- || Oraxol (oral paclitaxel/encequidar) / Athenex
New P2 trial: A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients (clinicaltrials.gov) - Nov 27, 2019
P2, N=40, Recruiting, Sponsor: Athenex, Inc.
- | Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment change: KX-ORAX-010t: A Study of Oraxol in Subjects With Cutaneous Angiosarcoma (clinicaltrials.gov) - Oct 17, 2019
P1, N=25, Recruiting, Sponsor: Athenex, Inc.
Trial primary completion date: Dec 2020 --> Dec 2025 N=14 --> 25
- ||||| Oraxol (paclitaxel oral) / Athenex
Clinical: We shall be presenting #studydesign of #multinational #pilot #study of #oral #paclitaxel (#ORAXOL) in pts with #cutaneous #angiosarcomas as a TiP poster on Sat #ESMO19. Come join us! @saxotomy @RobinL_Jones @vinodravi #CUHKSarcoma @CUHKMedicine @MDAndersonNews @royalmarsdenNHS (Twitter) - Sep 25, 2019
- Oraxol (paclitaxel oral) / Athenex, Cyramza (ramucirumab) / Eli Lilly
A phase Ib study of oraxol in combination with ramucirumab in patients with gastric or esophageal cancers who failed previous chemotherapy (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_2445;
P1b
Clinical trial identification: NCT02970539. Legal entity responsible for the study: Athenex Inc.
- Oraxol (paclitaxel oral) / Athenex
A pilot study of oral paclitaxel (ORAXOL) in subjects with cutaneous angiosarcomas (KX-ORAX-010) (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_1929;
P1
Legal entity responsible for the study: Athenex Inc. Funding: Athenex Inc.
- Oraxol (paclitaxel oral) / Athenex
An international randomized cross-over bio-equivalence study of oral paclitaxel + HM30181 compared with weekly intravenous (IV) paclitaxel in patients with advanced solid tumours (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_1500;
Clinical trial identification: ACTRN 12615000894594. Legal entity responsible for the study: Athenex.
- | Oraxol (oral paclitaxel/encequidar) / Athenex
New P1 trial: A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel (clinicaltrials.gov) - Jul 28, 2019
P1, N=44, Completed, Sponsor: Athenex, Inc.
- | Oraxol (oral paclitaxel/encequidar) / Athenex
Trial completion date, Trial primary completion date, Combination therapy: Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers (clinicaltrials.gov) - Jun 17, 2019
P1b, N=18, Recruiting, Sponsor: Athenex, Inc.
Legal entity responsible for the study: Athenex. Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019
- || Oraxol (oral paclitaxel/encequidar) / Athenex
New P1 trial: The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol (clinicaltrials.gov) - Mar 27, 2019
P1, N=36, Recruiting, Sponsor: Athenex, Inc.
- ||||| Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment closed, Trial primary completion date, Metastases: KX-ORAX-001: Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer (clinicaltrials.gov) - Feb 15, 2019
P3, N=402, Active, not recruiting, Sponsor: Athenex, Inc.
Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019 Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2019 --> Aug 2019
- | Oraxol (oral paclitaxel/encequidar) / Athenex
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) - Jan 11, 2019
P1, N=30, Recruiting, Sponsor: Athenex, Inc.
Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2019 --> Aug 2019 Trial completion date: Dec 2018 --> Mar 2020 | Trial primary completion date: Nov 2018 --> Sep 2019
- ||| Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment open, Trial primary completion date, Combination therapy, Metastases: KEYNOTE-E06: Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Jan 10, 2019
P1, N=114, Recruiting, Sponsor: Athenex, Inc.
Trial completion date: Dec 2018 --> Mar 2020 | Trial primary completion date: Nov 2018 --> Sep 2019 Not yet recruiting --> Recruiting | Trial primary completion date: Jul 2020 --> Oct 2020
- | Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment open: KX-ORAX-010t: A Study of Oraxol in Subjects With Cutaneous Angiosarcoma (clinicaltrials.gov) - Nov 23, 2018
P1, N=14, Recruiting, Sponsor: Athenex, Inc.
Not yet recruiting --> Recruiting | Trial primary completion date: Jul 2020 --> Oct 2020 Not yet recruiting --> Recruiting
- | Oraxol (oral paclitaxel/encequidar) / Athenex
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) - Aug 13, 2018
P1, N=30, Recruiting, Sponsor: Athenex, Inc.
Not yet recruiting --> Recruiting Trial completion date: Aug 2018 --> Dec 2018 | Trial primary completion date: Jun 2018 --> Nov 2018
- | Oraxol (oral paclitaxel/encequidar) / Athenex
New P1 trial, Combination therapy, Metastases: KEYNOTE-E06: Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Jul 16, 2018
P1, N=114, Not yet recruiting, Sponsor: Athenex, Inc.
- | Oraxol (oral paclitaxel/encequidar) / Athenex
New P1 trial: KX-ORAX-010t: A Study of Oraxol in Subjects With Cutaneous Angiosarcoma (clinicaltrials.gov) - Jul 15, 2018
P1, N=14, Not yet recruiting, Sponsor: Athenex, Inc.
- Oraxol (oral paclitaxel/encequidar) / Athenex
Trial primary completion date, Combination therapy: Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers (clinicaltrials.gov) - Apr 9, 2018
P1b, N=18, Recruiting, Sponsor: Kinex Pharmaceuticals Inc
Trial completion date: Aug 2018 --> Dec 2018 | Trial primary completion date: Jun 2018 --> Nov 2018 Trial primary completion date: Dec 2017 --> Dec 2018
- |||| Oraxol (oral paclitaxel/encequidar) / Athenex
Trial primary completion date, Metastases: KX-ORAX-001: Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer (clinicaltrials.gov) - Jan 10, 2018
P3, N=360, Recruiting, Sponsor: Kinex Pharmaceuticals Inc
Trial primary completion date: Dec 2017 --> Dec 2018 Trial primary completion date: Nov 2017 --> Nov 2019
- | Biomarker, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Oct 20, 2017
P2, N=1920, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Trial primary completion date: Nov 2017 --> Nov 2019 Trial primary completion date: Dec 2018 --> Dec 2020
- | Oraxol (oral paclitaxel/encequidar) / Athenex
New P1 trial: KX-ORAX-007: A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients (clinicaltrials.gov) - May 24, 2017
P1, N=24, Recruiting, Sponsor: Kinex Pharmaceuticals Inc
- Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment open, Combination therapy: Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers (clinicaltrials.gov) - May 15, 2017
P1b, N=18, Recruiting, Sponsor: Kinex Pharmaceuticals Inc
Trial primary completion date: Dec 2018 --> Dec 2020 Not yet recruiting --> Recruiting
- Oraxol (oral paclitaxel/encequidar) / Athenex
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) - May 3, 2017
P1, N=30, Recruiting, Sponsor: Kinex Pharmaceuticals Inc
Not yet recruiting --> Recruiting Trial primary completion date: Mar 2018 --> Jun 2018
- | Oraxol (oral paclitaxel/encequidar) / Athenex
Trial completion, Metastases: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies (clinicaltrials.gov) - Dec 16, 2016
P1, N=34, Completed, Sponsor: Kinex Pharmaceuticals Inc
Trial primary completion date: Mar 2018 --> Jun 2018 Active, not recruiting --> Completed
- Biomarker, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Dec 7, 2016
P2, N=1920, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Active, not recruiting --> Completed Trial primary completion date: May 2018 --> Dec 2018
- | Oraxol (oral paclitaxel/encequidar) / Athenex
New P1 trial, Combination therapy: Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers (clinicaltrials.gov) - Nov 22, 2016
P1b, N=18, Not yet recruiting, Sponsor: Kinex Pharmaceuticals Inc
- Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment open, Metastases: A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies (clinicaltrials.gov) - Nov 15, 2016
P1, N=30, Recruiting, Sponsor: Kinex Pharmaceuticals Inc
Trial primary completion date: May 2018 --> Dec 2018 Not yet recruiting --> Recruiting
- Biomarker, Enrollment change, Trial primary completion date, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Jul 13, 2016
P2, N=1920, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
Not yet recruiting --> Recruiting N=1200 --> 1920 | Trial primary completion date: Sep 2017 --> May 2018
- | Oraxol (oral paclitaxel/encequidar) / Athenex
New P1 trial, Metastases: A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies (clinicaltrials.gov) - Apr 6, 2016
P1, N=30, Not yet recruiting, Sponsor: Kinex Pharmaceuticals Inc
- Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment closed, Trial primary completion date, Metastases: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies (clinicaltrials.gov) - Mar 9, 2016
P1, N=34, Active, not recruiting, Sponsor: Kinex Pharmaceuticals Inc
N=1200 --> 1920 | Trial primary completion date: Sep 2017 --> May 2018 Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2015 --> Feb 2016
- |||||| Oraxol (oral paclitaxel/encequidar) / Athenex
Enrollment open, Metastases: KX-ORAX-001: Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer (clinicaltrials.gov) - Dec 5, 2015
P3, N=360, Recruiting, Sponsor: Kinex Pharmaceuticals Inc
Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2015 --> Feb 2016 Not yet recruiting --> Recruiting
- |||||||||| Oraxol (oral paclitaxel/encequidar) / Athenex
New P3 trial, Metastases: KX-ORAX-001: Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer (clinicaltrials.gov) - Nov 3, 2015
P3, N=360, Not yet recruiting, Sponsor: Kinex Pharmaceuticals Inc
- Oraxol (oral paclitaxel/encequidar) / Athenex
Trial primary completion date, Metastases: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies (clinicaltrials.gov) - Jun 16, 2015
P1, N=34, Recruiting, Sponsor: Kinex Pharmaceuticals Inc
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2014 --> Nov 2015