Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-04-30

Brief Summary

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Pharmacokinetic, bioequivalence study

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPARC1210

Intravenous administration of SPARC1210

Group Type EXPERIMENTAL

SPARC1210

Intervention Type DRUG

Reference1210

Intravenous administration of Reference1210

Group Type ACTIVE_COMPARATOR

Reference1210

Intervention Type DRUG

Interventions

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SPARC1210

Intervention Type DRUG

Reference1210

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject has given written, informed consent and is available for the entire study.
* Histologically or cytologically confirmed diagnosis of breast cancer;
* Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
* Age 18 years or more

Exclusion Criteria

* Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
* Presence of clinically evident 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 4.0);
* Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No