Pharmacokinetic, Safety and Tolerability Study of SPARC1028

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited Identifier:
First received: February 24, 2011
Last updated: March 8, 2016
Last verified: March 2016
Evaluation of pharmacokinetic profile of SPARC1028

Condition Intervention Phase
Solid Tumor in Advanced Stage
Drug: SPARC1028
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • Determination of Maximum Tolerated Dose (MTD) during dose escalation [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: Yes ]
    MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects

Secondary Outcome Measures:
  • Establishing pharmacokinectic profile at each dose level for SPARC1028 [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 36
Study Start Date: May 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARC1028 Drug: SPARC1028
SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01305512

United States, New York
SPARC Site 1
Buffalo, New York, United States
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT01305512     History of Changes
Other Study ID Numbers: CLR_10_28 
Study First Received: February 24, 2011
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Sun Pharma Advanced Research Company Limited:
Taxane processed this record on May 25, 2016