Pharmacokinetic, Safety and Tolerability Study of SPARC1028

Evaluation of pharmacokinetic profile of SPARC1028

Study Overview

• Status: Completed
• Conditions: Solid Tumor in Advanced Stage
• Intervention / Treatment: Drug: SPARC1028

Detailed Description

This is a phase I study of SPARC1028 and recommend phase II dose of SPARC1028 administered once a week for 3 weeks, followed by 1 week of rest.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States
      • SPARC Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option.
• Age ≥18 years
• ECOG Performance Status ≤ 1.
• Estimated life expectancy of at least 12-weeks;

Exclusion Criteria:

• Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
• Known hypersensitivity to the study drugs
• Treatment with any anti-cancer agents within 28 days of study entry
• Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPARC1028	Drug: SPARC1028; SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Maximum Tolerated Dose (MTD) during dose escalation	MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects	One 21-day treatment cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishing pharmacokinectic profile at each dose level for SPARC1028	Plasma levels of SPARC1028 will be determined and PK parameters viz., Cmax, AUC0-t, AUC0-∞, MRT, Tmax, t½, Kel, Vd, Cl for SPARC1028 will be evaluated	One 21-day treatment cycle

Collaborators and Investigators

• Sponsor: Sun Pharma Advanced Research Company Limited

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Tumor; Taxane; Solid
• Other Study ID Numbers: CLR_10_28