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To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332549
Recruitment Status : Withdrawn (After meeting with the FDA, SPARC concludes a BE study will not be required)
First Posted : April 2, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Tracking Information
First Submitted Date  ICMJE March 26, 2020
First Posted Date  ICMJE April 2, 2020
Last Update Posted Date June 1, 2020
Estimated Study Start Date  ICMJE April 27, 2020
Estimated Primary Completion Date January 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • Maximum observed plasma concentration Plasma [ Time Frame: 8 weeks ]
  • area under the plasma concentration versus time curve, from time 0 to the last measurable concentration [ Time Frame: 8 weeks ]
  • area under the plasma concentration versus time curve from time 0 to infinity [ Time Frame: 8 weeks ]
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 8 weeks ]
    shall be coded per CTCAE, Version 5.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer
Official Title  ICMJE A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Suspension (PICS) in Subjects With Locally Recurrent or Metastatic Breast Cancer.
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 Metastatic Breast Cancer subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Breast Cancer
  • Locally Recurrent Cancer
Intervention  ICMJE Drug: PICS (Reconstitution Method 1 or 2)
dose: 260mg/m2 Frequency: 2 period cross over study Route of administration : intravenous infusion duration of therapy: 2 cycles of PICS
Study Arms  ICMJE
  • Active Comparator: Reconstitution Method 1
    Intervention: Drug: PICS (Reconstitution Method 1 or 2)
  • Active Comparator: Reconstitution Method 2
    Intervention: Drug: PICS (Reconstitution Method 1 or 2)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 28, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
44
Estimated Study Completion Date  ICMJE January 28, 2021
Estimated Primary Completion Date January 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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-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

  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:

  1. 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. Treatment with investigational agents or participation in a clinical trial within 30 days of study entry
  9. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04332549
Other Study ID Numbers  ICMJE SDO-006-20-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sun Pharma Advanced Research Company Limited
Study Sponsor  ICMJE Sun Pharma Advanced Research Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharma Advanced Research Company Limited
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP