Status:
WITHDRAWN
To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Sun Pharma Advanced Research Company Limited
Conditions:
Metastatic Breast Cancer
Locally Recurrent Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A randomized, multi center, open label, two-period, single dose, crossover study to evaluate the bioavailability and safety of Paclitaxel Injection Concentrate for Suspension in Locally Recurrent or M...
Eligibility Criteria
Inclusion
- The subject has given written, informed consent (or legally acceptable representative /impartial witness when applicable) and is available for the duration of study
- Histologically or cytologically confirmed diagnosis of breast cancer with adequate documentation of prior therapy with an anthracycline unless clinically contraindicated
- Locally recurrent or MBC for which taxane-based therapy is an appropriate treatment option
- Male or female aged greater than equal to 18 years
- ECOG performance status less than equal to 1
- Estimated life expectancy of at least 12 weeks
- 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:
- 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
- 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-Provera™) 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
- 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)
- 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
- Females subjects of child-bearing potential must have a negative urine pregnancy test
- Female subjects must be non-lactating and non-breastfeeding
- Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
Exclusion
- Known hypersensitivity to the study drug or their excipients (cholesteryl sulfate, caprylic acid, polyvinylpyrrolidone, ethanol, polyethylene glycol)
- Inability to undergo venipuncture and/or tolerate venous access
- Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy
- Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 5.0)
- 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
- 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
- Positive laboratory exclusion test (HIV, HBsAg, or HCV)
- Treatment with investigational agents or participation in a clinical trial within 30 days of study entry
- Failure of prior taxane therapy for metastatic disease or for adjuvant therapy within previous 6 months of screening visit
- 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
- Evidence or history of bleeding diathesis or coagulopathy within 6 months prior to screening visit
- Uncontrolled cardiac disease, including: congestive heart failure (CHF) \> Class II per New York Heart Association (NYHA), history of hypertensive crisis
- Active clinical infection which in the treating investigator's opinion renders the subject ineligible or can confound the study
- Serious non-healing wound, ulcer or bone fracture
- Unresolved toxicity higher than CTCAE Version 5.0 Grade 1 (excluding alopecia, anemia) attributed to any prior therapy/procedure
- History of gastrointestinal perforation within 6 months prior to screening visit.
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04332549
Start Date
April 27 2020
End Date
January 28 2021
Last Update
June 1 2020
Active Locations (22)
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1
SPARC Site 12
Visakhapatnam, Andhra Pradesh, India, 530017
2
SPARC Site 21
Ahmedabad, Gujarat, India, 380016
3
SPARC Site 22
Surat, Gujarat, India, 395002
4
SPARC Site 4
Bangalore, Karnataka, India, 560027