Bioavailability Study of Paclitaxel Injection Concentrate for Suspension in Subjects with Locally Recurrent or Metastatic Breast Cancer.

Phase 1

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2020/03/024065
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

This  is a randomized, multi center, open label, two-period, single dose, crossover study to evaluate the bioavailability and safety of PICS in Locally Recurrent or Metastatic Breast Cancer subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-27
• Last Update Posted: 2020-10-13

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 1. The subject has given written, informed consent (or legally acceptable representative /impartial witness when applicable) and is available for the duration of study 2.
• Histologically or cytologically confirmed diagnosis of breast cancer with adequate documentation of prior therapy with an anthracycline unless clinically contraindicated 3.
• Locally recurrent or MBC for which taxane-based therapy is an appropriate treatment option 4.
• Male or female aged greater than equal to 18 years 5.
• ECOG performance status less than equal to 1 6.
• Estimated life expectancy of at least 12 weeks 7.
• Adequate organ and immune system function as indicated by the following laboratory values, obtained less than equal to 2 weeks prior to dosing for Period 1 and Period 2: 8.
• Any chemotherapy, targeted therapy, major surgery, or irradiation must have been completed at least 4 weeks before enrollment (6 weeks for mitomycin C or nitrosurea); immune therapy or hormonal therapy (except palliative bisphosphonate therapy for bone pain) must be completed 2 weeks before enrollment and subjects must have recovered from all toxicities incurred as a result of previous therapy except alopecia; use of targeted therapy or antibody therapy should have been completed for at least 5 half-lives of the respective therapy before enrollment.
• Use of narcotic analgesics such as dihydrocodeine and medicinal herbs such as St. John’s Wort, which may act as inhibitors/inducers of CYP2C8 and CYP3A4, must have been discontinued at least 2 weeks and 4 weeks respectively before enrollment 9.
• Subjects of child bearing potential must practice an acceptable method of birth control as judged by the investigator • Medically acceptable methods of birth control include the use of either a contraceptive implant or a contraceptive injection (e.g., Depo-Proveraâ„¢) or an intrauterine device, same sex partner or vasectomized partner or an oral contraceptive taken continually within the past three months and which the subject agrees to continue using during the study • To adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or a spermicide at least 2 months prior to study entry and must continue to use contraception for the duration of the study 10.
• Female subjects who are postmenopausal for at least 1 year as per investigator’s discretion, or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) 11.
• Male subjects enrolled in the trial cannot father a child and are advised to prevent passage of semen to their sexual partner during intercourse using acceptable methods as judged by the investigator for the duration of the study 12.
• Females subjects of child-bearing potential must have a negative urine pregnancy test 13.
• Female subjects must be non-lactating and non-breastfeeding 14.
• Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing.

Exclusion Criteria

• Known hypersensitivity to the study drug or their excipients (cholesteryl sulfate, caprylic acid, polyvinylpyrrolidone, ethanol, polyethylene glycol) 2.
• Inability to undergo venipuncture and/or tolerate venous access 3.
• Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy 4.
• Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 5.0) 5.
• Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study or confound the study 6.
• Presence of pleural/ascitic fluid which cannot be definitively treated prior to dosing and during the PK blood draws in each period (Period 1 and Period 2) and if there is re-accumulation of fluid (greater than 5%) greater than 2 weeks after definitive management 7.
• Positive laboratory exclusion test (HIV, HBsAg, or HCV) 8.
• Failure of prior taxane therapy for metastatic disease or for adjuvant therapy within previous 6 months of screening visit 10.
• Subjects taking concurrent medications that may act as inhibitors/inducers of CYP2C8 and CYP3A4 within 2 weeks of screening and during Periods 1 and 2 11.
• Evidence or history of bleeding diathesis or coagulopathy within 6 months prior to screening visit 12.
• Uncontrolled cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA), history of hypertensive crisis 13.
• Active clinical infection which in the treating investigator’s opinion renders the subject ineligible or can confound the study 14.
• Serious non-healing wound, ulcer or bone fracture 15.
• Unresolved toxicity higher than CTCAE Version 5.0 Grade 1 (excluding alopecia, anemia) attributed to any prior therapy/procedure 16.
• History of gastrointestinal perforation within 6 months prior to screening visit.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration Plasma, area under the plasma concentration versus time curve, from time 0 to the last measurable concentration and area under the plasma concentration versus time curve from time 0 to infinity of PICS under various reconstitution conditions.	8 weeks

Secondary Outcome Measures

Name	Time	Method
number of subjects with treatment emergent adverse events	safety and tolerability profile of PICS under various reconstitution conditions

Trial Locations

Locations (23)

Baraskar Hospital and Research Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

Government Medical College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

HCG Manavata Cancer Centre; 🇮🇳 Nashik, MAHARASHTRA, India

Healthcare Global Enterprises Ltd.; 🇮🇳 Bangalore, KARNATAKA, India

Indrayani Hospital and Cancer Institute; 🇮🇳 Pune, MAHARASHTRA, India

Kailash Cancer Hospital & Research Center; 🇮🇳 Vadodara, GUJARAT, India

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Kolhapur Cancer Centre Pvt. Ltd; 🇮🇳 Kolhapur, MAHARASHTRA, India

Krupamayi Hospitals; 🇮🇳 Aurangabad, MAHARASHTRA, India

M S Ramaiah Medical College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

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Baraskar Hospital and Research Centre

🇮🇳Nagpur, MAHARASHTRA, India

Dr Jaiprakash Baraskar

Principal investigator

9422108822

jpcancercare@gmail.com