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Clinical research study of SPARC1612 in breast cancer

A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of SPARC1612 and reference1612 in Subjects with Locally Recurrent or Metastatic Breast Cancer (MBC).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/06/007043
Enrollment
20
Registered
2016-06-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: null- Metastatic breast cancer

Interventions

Intervention1: PICN: administered as 250mg/m2 for 25 minutes Control Intervention1: Abraxane: administered as 250mg/m2 for 30 minutes

Sponsors

Sun Pharma Advanced Research Company Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - 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 - Locally recurrent or MBC for which taxane-based therapy is an appropriate treatment option - Male or female aged >= 18 years

Exclusion criteria

Exclusion criteria: - Presence of clinically symptomatic active CNS metastases - Pre-existing clinically significant peripheral neuropathy - Inability to undergo venipuncture and/or tolerate venous access - Known hypersensitivity to either of the study drugs or their excipients

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameter: Cmax, AUC0-t and AUC0-â?? Timepoint: up to 72 hours—

Secondary

MeasureTime frame
Adverse eventsTimepoint: 51 days—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Ltd

clinical.trials@sparcmail.com912266455645

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026