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OpenTrials
Completed

NCT Number: NCT01305512

Pharmacokinetic, Safety and Tolerability Study of SPARC1028

Evaluation of pharmacokinetic profile of SPARC1028

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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

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

SPARC1028

Drug

SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest

Primary outcomes

  1. Determination of Maximum Tolerated Dose (MTD) during dose escalation

    Time frame: One 21-day treatment cycle

    MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects

Secondary outcomes

  1. Establishing pharmacokinectic profile at each dose level for SPARC1028

    Time frame: One 21-day treatment cycle

    Plasma levels of SPARC1028 will be determined and PK parameters viz., Cmax, AUC0-t, AUC0-∞, MRT, Tmax, t½, Kel, Vd, Cl for SPARC1028 will be evaluated

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 28, 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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