Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Solid Tumor in Advanced Stage

Treatments: Drug: SPARC1023 II; Drug: SPARC1023 I

Study type: Interventional

Funder types: Industry

Identifiers

NCT01304303

CLR_10_23

Details and patient eligibility

About

Phase I study of SPARC1023 alone and in combination with carboplatin

Full description

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

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

SPARC1023 I

Experimental group

Treatment:

Drug: SPARC1023 I

SPARC1023 II

Experimental group

Treatment:

Drug: SPARC1023 II