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Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Sun Pharma Advanced Research Company Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01304303
First received: February 23, 2011
Last updated: March 8, 2016
Last verified: March 2016

February 23, 2011
March 8, 2016
October 2011
June 2016   (final data collection date for primary outcome measure)
Determination of MTD [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: Yes ]
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.
Determination of MTD [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: Yes ]
MTD for PICN in combination with carboplatin will be determined. MTD will be defined as the PICN dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.
Complete list of historical versions of study NCT01304303 on ClinicalTrials.gov Archive Site
Establishing the pharmacokinetic profile [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: No ]
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.
Establishing the pharmacokinetic profile [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: No ]
Plasma levels of PICN and Carboplatin will be determined and PK parameters viz. Cmax, AUC0-t, AUC 0-∞, MRT, Tmax, t½ , Kel, Vd for PICN in combination with carboplatin will be evaluated.
Not Provided
Not Provided
 
Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination
Not Provided
Phase I study of SPARC1023 alone and in combination with carboplatin
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor in Advanced Stage
  • Drug: SPARC1023 I
    IV administration
  • Drug: SPARC1023 II
    IV administration
  • Experimental: SPARC1023 I
    Intervention: Drug: SPARC1023 I
  • Experimental: SPARC1023 II
    Intervention: Drug: SPARC1023 II
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
July 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Shravanti Bhowmik, MD 9122664556454 ext 5626 shravanti.bhowmik@sparcmail.com
United States
 
NCT01304303
CLR_10_23
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
March 2016

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