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Pharmacokinetic, Safety and Tolerability Study of SPARC1028

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01305512
First received: February 24, 2011
Last updated: October 20, 2016
Last verified: October 2016

February 24, 2011
October 20, 2016
May 2012
June 2016   (final data collection date for primary outcome measure)
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
Determination of Maximum Tolerated Dose (MTD) during dose escalation [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: Yes ]
MTD for PICN will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects
Complete list of historical versions of study NCT01305512 on ClinicalTrials.gov Archive Site
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
Establishing pharmacokinectic profile at each dose level for PICN [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: No ]
Plasma levels of PICN will be determined and PK parameters viz., Cmax, AUC0-t, AUC0-∞, MRT, Tmax, t½, Kel, Vd, Cl for PICN will be evaluated
Not Provided
Not Provided
 
Pharmacokinetic, Safety and Tolerability Study of SPARC1028
Not Provided
Evaluation of pharmacokinetic profile of SPARC1028
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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor in Advanced Stage
Drug: SPARC1028
SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest
Experimental: SPARC1028
Intervention: Drug: SPARC1028
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01305512
CLR_10_28
No
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
Sun Pharma Advanced Research Company Limited
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP