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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03109249 |
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Date of registration:
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06/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer
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Scientific title:
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Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer |
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Date of first enrolment:
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January 14, 2017 |
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Target sample size:
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142 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03109249 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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India
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The subject has given written, informed consent and is available for the duration of
study
- Histologically or cytologically confirmed diagnosis of breast cancer
- Male or female aged = 18 years
- 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 Criteria:
- Known hypersensitivity to either of the study drugs or their excipients
- Inability to undergo venipuncture and/or tolerate venous access
- Pre-existing clinically significant peripheral neuropathy
- Positive laboratory exclusion test (HIV, HBsAg, or HCV)
- Treatment with investigational agents or participation in clinical trial within 30
days of study entry
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Recurrent or Metastatic Breast Cancer
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Intervention(s)
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Drug: SPARC1613
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Drug: Reference1613
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Primary Outcome(s)
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Maximum observed concentration (Cmax)
[Time Frame: Pre-dose,post dose upto 3 days]
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Secondary ID(s)
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CLR_16_13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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