CompletedPhase 1

A PK Study of Oraxol in Breast Cancer Patients

China24 participantsStarted 2019-04-22

Plain-language summary

This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed written informed consent
✓. Women ≥18 years of age on day of consent
✓. Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist.
✓. Measurable disease as per RECIST v1.1 criteria
✓. Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:
✓. Adequate liver function as demonstrated by:
✓. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

✕. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
✕. If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
✕. Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
✕. Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
✕. Known CNS metastasis, including leptomeningeal involvement
✕. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
✕. Are currently receiving other medications intended for the treatment of their malignancy
✕. Women who are pregnant or breastfeeding

What they're measuring

Cmax

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

Cmin

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

Cavg

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

AUC0-t

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

AUC

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

Trial details

NCT IDNCT04993040

SponsorAthenex, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-09

View on ClinicalTrials.gov More Breastcancer trials

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed written informed consent
✓. Women ≥18 years of age on day of consent
✓. Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist.
✓. Measurable disease as per RECIST v1.1 criteria
✓. Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:
✓. Adequate liver function as demonstrated by:
✓. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

✕. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
✕. If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
✕. Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
✕. Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
✕. Known CNS metastasis, including leptomeningeal involvement
✕. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
✕. Are currently receiving other medications intended for the treatment of their malignancy
✕. Women who are pregnant or breastfeeding

What they're measuring

Cmax

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

Cmin

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

Cavg

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

AUC0-t

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

AUC

Timeframe: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose