Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

Phase 1

Completed

• Conditions: Solid Tumor in Advanced Stage
• Interventions: Drug: SPARC1023 I; Drug: SPARC1023 II

• Registration Number: NCT01304303
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

Phase I study of SPARC1023 alone and in combination with carboplatin

Detailed Description

Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.

Study Timeline

• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-25
• Study Start: 2011-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Age ≥18 years
• ECOG Performance Status ≤ 1.
• Estimated life expectancy of at least 12-weeks;
• Measurable disease as per RECIST guideline (Version 1.1);

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPARC1023 I	SPARC1023 I	-
SPARC1023 II	SPARC1023 II	-

Primary Outcome Measures

Name	Time	Method
Determination of MTD	One 21-day treatment cycle	MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.

Secondary Outcome Measures

Name	Time	Method
Establishing the pharmacokinetic profile	One 21-day treatment cycle	Plasma levels of SPARC1023 and Carboplatin will be determined and PK parameters viz. Cmax, AUC0-t, AUC 0-∞, MRT, Tmax, t½ , Kel, Vd for SPARC1023 in combination with carboplatin will be evaluated.

Trial Locations

Locations (1)

SPARC Site 1; 🇺🇸 Buffalo, New York, United States