Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-10-31

Brief Summary

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Phase I study of SPARC1023 alone and in combination with carboplatin

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Detailed Description

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

Conditions

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Solid Tumor in Advanced Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPARC1023 I

Group Type EXPERIMENTAL

SPARC1023 I

Intervention Type DRUG

IV administration

SPARC1023 II

Group Type EXPERIMENTAL

SPARC1023 II

Intervention Type DRUG

IV administration

Interventions

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SPARC1023 I

IV administration

Intervention Type DRUG

SPARC1023 II

IV administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No