Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer
NCT ID: NCT03109249
Last Updated: 2019-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
142 participants
INTERVENTIONAL
2017-01-14
2018-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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SPARC1613
Intravenous administration of SPARC1613
Reference1613
Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)
Reference 1613
Intravenous administration of Reference1613
SPARC1613
Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)
Interventions
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SPARC1613
Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)
Reference1613
Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sun Pharma Advanced Research Company Limited
INDUSTRY
Responsible Party
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Locations
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SPARC Site 40
Visakhapatnam, Andhra Pradesh, India
SPARC Site 20
Ahmedabad, Gujarat, India
SPARC site 39
Ahmedabad, Gujarat, India
SPARC site 38
Karamsad, Gujarat, India
SPARC Site 27
Surat, Gujarat, India
SPARC Site 35
Surat, Gujarat, India
SPARC Site 24
Vadodara, Gujarat, India
SPARC Site 13
Bangalore, Karnataka, India
SPARC site 41
Bangalore, Karnataka, India
SPARC Site 28
Bangalore, Karnataka, India
SPARC Site 22
Belagavi, Karnataka, India
SPARC Site 7
Mangalore, Karnataka, India
SPARC Site 25
Aurangabad, Maharashtra, India
SPARC Site 23
Aurangabad, Maharashtra, India
SPARC Site 2
Mumbai, Maharashtra, India
SPARC Site 12
Nagpur, Maharashtra, India
SPARC site 34
Nashik, Maharashtra, India
SPARC Site 37
Nashik, Maharashtra, India
SPARC Site 18
Pune, Maharashtra, India
SPARC Site 4
Pune, Maharashtra, India
SPARC Site 9
Aurangabad, Marashtra, India
SPARC Site 15
Khordha, Odisha, India
SPARC site 42
Chennai, Tamil Nadu, India
SPARC Site 32
Madurai, Tamil Nadu, India
Countries
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Other Identifiers
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CLR_16_13
Identifier Type: -
Identifier Source: org_study_id
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