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OpenTrials
Completed

NCT Number: NCT01304303

Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

Phase I study of SPARC1023 alone and in combination with carboplatin

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Key information

Conditions

Solid Tumor in Advanced Stage Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SPARC Site 1

Buffalo, New York, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPARC1023 I

Drug

IV administration

SPARC1023 II

Drug

IV administration

Primary outcomes

  1. Determination of MTD

    Time frame: 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 outcomes

  1. Establishing the pharmacokinetic profile

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2011
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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