Overview

This trial has been completed.

Condition solid tumor in advanced stage
Treatment sparc1028
Phase phase 1
Sponsor Sun Pharma Advanced Research Company Limited
Start date May 2012
End date June 2016
Trial size 36 participants
Trial identifier NCT01305512, CLR_10_28

Summary

Evaluation of pharmacokinetic profile of SPARC1028

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
sparc1028
SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest

Primary Outcomes

Measure
Determination of Maximum Tolerated Dose (MTD) during dose escalation
time frame: One 21-day treatment cycle

Secondary Outcomes

Measure
Establishing pharmacokinectic profile at each dose level for SPARC1028
time frame: One 21-day treatment cycle

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sun Pharma Advanced Research Company Limited.