Trial Outcomes & Findings for A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients (NCT NCT03165955)

NCT ID: NCT03165955

Last Updated: 2025-03-12

Results Overview

PK parameters were summarized using the mean, SD

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 28 participants
• Primary outcome timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
• Results posted on: 2025-03-12

Participant Flow

A total of 31 subjects were screened; 3 subjects were screen failures and were not included in the analysis

Participant milestones

Measure	Oraxol (Oral Paclitaxel Plus HM30181) Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Screening/Baseline STARTED	31
Screening/Baseline COMPLETED	28
Screening/Baseline NOT COMPLETED	3
Treatment STARTED	28
Treatment COMPLETED	20
Treatment NOT COMPLETED	8

Reasons for withdrawal

Measure	Oraxol (Oral Paclitaxel Plus HM30181) Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Treatment Withdrawal by Subject	3
Treatment Death	1
Treatment Adverse Event	1
Treatment Progressive disease	3

Baseline Characteristics

A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients

Baseline characteristics by cohort

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=28 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Age, Continuous	56.6 years STANDARD_DEVIATION 9.04 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Taiwan	28 participants n=5 Participants
ECOG 0	24 Participants n=5 Participants
ECOG 1	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the mean, SD

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_AUC (0-52) Week 1	3419 ng*hr/mL Standard Deviation 1475
PK Parameters for paclitaxel_AUC (0-52) Week 4	3224 ng*hr/mL Standard Deviation 1150

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the mean, SD

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_Cmax Week 1	366 ng/mL Standard Deviation 143
PK Parameters for paclitaxel_Cmax Week 4	356 ng/mL Standard Deviation 140

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the mean, SD

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_Ctrough(24) Week 1	11.0 ng/mL Standard Deviation 4.0
PK Parameters for paclitaxel_Ctrough(24) Week 4	12.5 ng/mL Standard Deviation 8.7

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the mean, SD

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_Ctrough(48) Week 1	12.6 ng/mL Standard Deviation 4.3
PK Parameters for paclitaxel_Ctrough(48) Week 4	11.7 ng/mL Standard Deviation 3.3

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the mean, SD

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_Cmax(0-24) Week 1	312 ng/mL Standard Deviation 132
PK Parameters for paclitaxel_Cmax(0-24) Week 4	267 ng/mL Standard Deviation 135

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the mean, SD

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_Cmax(24-48) Week 1	274 ng/mL Standard Deviation 144
PK Parameters for paclitaxel_Cmax(24-48) Week 4	298 ng/mL Standard Deviation 127

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the mean, SD

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_Cmax(48-52) Week 1	287 ng/mL Standard Deviation 144
PK Parameters for paclitaxel_Cmax(48-52) Week 4	288 ng/mL Standard Deviation 144

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the median, minimum, maximum

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_tmax(0-24) Week 1	1.05 hour Interval 0.97 to 2.12
PK Parameters for paclitaxel_tmax(0-24) Week 4	1.07 hour Interval 0.93 to 2.12

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the median, minimum, maximum

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_tmax(24-48) Week 1	25.03 hour Interval 24.47 to 27.03
PK Parameters for paclitaxel_tmax(24-48) Week 4	25.00 hour Interval 22.78 to 27.33

PRIMARY outcome

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Population: Twenty-five subjects completed 2-period PK assessment.

PK parameters were summarized using the median, minimum, maximum

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=25 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
PK Parameters for paclitaxel_tmax(48-52) Week 1	49.02 hour Interval 48.22 to 51.03
PK Parameters for paclitaxel_tmax(48-52) Week 4	49.03 hour Interval 47.05 to 51.05

SECONDARY outcome

Timeframe: From enrollment through study completion, approximately 17 weeks

Population: Safety Analysis Population included all subjects who received at least 1 dose of study treatment.

Safety was assessed by evaluating treatment-emergent adverse events (TEAEs) including SAEs, laboratory evaluations (hematology, blood chemistry, and urinalysis), vital signs, physical examinations, and electrocardiograms (ECGs).

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=28 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Safety of Oraxol in Breast Cancer Patients Subjects with At Least One TEAE	27 Participants
Safety of Oraxol in Breast Cancer Patients TEAE leading to dose interruption or reduction	19 Participants
Safety of Oraxol in Breast Cancer Patients TEAE leading to study drug discontinuation	2 Participants
Safety of Oraxol in Breast Cancer Patients TEAE leading to discontinuation from the study	2 Participants
Safety of Oraxol in Breast Cancer Patients TEAE related to Oraxol	27 Participants
Safety of Oraxol in Breast Cancer Patients TEAE related to progression of disease	4 Participants
Safety of Oraxol in Breast Cancer Patients Serious TEAE	8 Participants
Safety of Oraxol in Breast Cancer Patients Death	1 Participants
Safety of Oraxol in Breast Cancer Patients TEAE with action taken for other treatments	24 Participants
Safety of Oraxol in Breast Cancer Patients Subjects with At Least One Grade ≥3 TEAE	19 Participants

SECONDARY outcome

Timeframe: From baseline through study completion, around 21 weeks

Population: The Response Evaluable Population included all subjects who received at least 1 dose of study treatment and had at least 1 post treatment tumor response evaluation.

Tumor response rate and 95% confidence interval (CI) were evaluated based on the number of subjects with any post-baseline CR or PR per RECIST 1.1 as assessed by the Investigator and the ICRRC.

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=26 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Response Rate Investigator Assessment · Complete response (CR)	0 Participants
Response Rate Investigator Assessment · Partial response (PR)	11 Participants
Response Rate Investigator Assessment · Stable disease (SD)	13 Participants
Response Rate Investigator Assessment · Progressive disease (PD)	1 Participants
Response Rate Investigator Assessment · Non-evaluable (NE)	1 Participants
Response Rate ICRRC Assessment · Complete response (CR)	0 Participants
Response Rate ICRRC Assessment · Partial response (PR)	10 Participants
Response Rate ICRRC Assessment · Stable disease (SD)	12 Participants
Response Rate ICRRC Assessment · Progressive disease (PD)	3 Participants
Response Rate ICRRC Assessment · Non-evaluable (NE)	0 Participants

SECONDARY outcome

Timeframe: From baseline through study completion, around 21 weeks

Population: The Response Evaluable Population included all subjects who received at least 1 dose of study treatment and had at least 1 post treatment tumor response evaluation.

PFS was analyzed based on the Response Evaluable Population. The Kaplan-Meier (KM) method was used to estimate the medians of these variables with 95% CIs.

The Response Evaluable Population included all subjects who received at least 1 dose of study treatment and had at least 1 posttreatment tumor response evaluation

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=26 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Progression-free Survival Investigator Assessment	NA weeks NA indicates that it cannot be estimated based on the data. Median OS is not reached
Progression-free Survival ICRRC Assessment	15.86 weeks Interval 15.0 to NA indicates that it cannot be estimated based on the data. Median OS is not reached

SECONDARY outcome

Timeframe: From baseline through study completion, around 21 weeks

Population: The Response Evaluable Population included all subjects who received at least 1 dose of study treatment and had at least 1 post treatment tumor response evaluation.

OS was analyzed based on the Response Evaluable Population. The Kaplan-Meier (KM) method was used to estimate the medians of these variables with 95% CIs.

The Response Evaluable Population included all subjects who received at least 1 dose of study treatment and had at least 1 posttreatment tumor response evaluation

Outcome measures

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=26 Participants Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Overall Survival	NA weeks NA indicates that it cannot be estimated based on the data. Median OS is not reached

Adverse Events

Oraxol (Oral Paclitaxel Plus HM30181)

Serious events: 8 serious events

Other events: 27 other events

Deaths: 1 deaths

Serious adverse events

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=28 participants at risk Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Blood and lymphatic system disorders Neutropenia	10.7% 3/28 • Number of events 8 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Hepatobiliary disorders Hepatitis acute	3.6% 1/28 • Number of events 1 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Infections and infestations Pneumonia	3.6% 1/28 • Number of events 1 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Infections and infestations Septic shock	3.6% 1/28 • Number of events 1 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Injury, poisoning and procedural complications Femur fracture	3.6% 1/28 • Number of events 2 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	3.6% 1/28 • Number of events 1 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Vascular disorders Deep vein thrombosis	3.6% 1/28 • Number of events 1 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.

Other adverse events

Measure	Oraxol (Oral Paclitaxel Plus HM30181) n=28 participants at risk Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Metabolism and nutrition disorders Decreased appetite	14.3% 4/28 • Number of events 5 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Metabolism and nutrition disorders Hypoalbuminaemia	7.1% 2/28 • Number of events 2 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Metabolism and nutrition disorders Hyponatraemia	7.1% 2/28 • Number of events 3 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Psychiatric disorders Insomnia	7.1% 2/28 • Number of events 3 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Gastrointestinal disorders Diarrhoea	57.1% 16/28 • Number of events 28 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Gastrointestinal disorders Nausea	32.1% 9/28 • Number of events 20 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Gastrointestinal disorders Vomiting	14.3% 4/28 • Number of events 5 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Gastrointestinal disorders Haemorrhoids	10.7% 3/28 • Number of events 3 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Gastrointestinal disorders Abdominal pain upper	7.1% 2/28 • Number of events 2 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Gastrointestinal disorders Mouth ulceration	7.1% 2/28 • Number of events 2 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Blood and lymphatic system disorders Neutropenia	57.1% 16/28 • Number of events 62 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Blood and lymphatic system disorders Anaemia	21.4% 6/28 • Number of events 16 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Blood and lymphatic system disorders Leukopenia	10.7% 3/28 • Number of events 15 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Skin and subcutaneous tissue disorders Alopecia	42.9% 12/28 • Number of events 14 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Skin and subcutaneous tissue disorders Pruritus	7.1% 2/28 • Number of events 2 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.1% 2/28 • Number of events 2 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Investigations Alanine aminotransferase increased	17.9% 5/28 • Number of events 13 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Investigations Aspartate aminotransferase increased	17.9% 5/28 • Number of events 12 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Investigations Blood lactate dehydrogenase increased	7.1% 2/28 • Number of events 8 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Investigations White blood cell count decreased	7.1% 2/28 • Number of events 5 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Nervous system disorders Neuropathy peripheral	14.3% 4/28 • Number of events 9 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Nervous system disorders Dizziness	7.1% 2/28 • Number of events 2 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Nervous system disorders Hypoaesthesia	7.1% 2/28 • Number of events 3 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Nervous system disorders Peripheral sensory neuropathy	7.1% 2/28 • Number of events 4 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Infections and infestations Upper respiratory tract infection	7.1% 2/28 • Number of events 3 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
Infections and infestations Urinary tract infection	7.1% 2/28 • Number of events 2 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
General disorders Fatigue	7.1% 2/28 • Number of events 3 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.
General disorders Malaise	7.1% 2/28 • Number of events 2 • An AE was any untoward medical occurrence in a subject or clinical investigation subject, and included events occurring from the time a subject signed the ICF through the last subject contact. The period is up to 21 weeks.

Additional Information

Regional Project Manager

Athenex Inc.

Phone: +886-978365735

Email: lmeiying@athenex.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place