Pharmacokinetic, Safety and Tolerability Study of SPARC1028

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01305512
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
Evaluation of pharmacokinetic profile of SPARC1028

Condition or disease Intervention/treatment Phase
Solid Tumor in Advanced Stage Drug: SPARC1028 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: SPARC1028 Drug: SPARC1028
SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01305512

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

Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT01305512     History of Changes
Other Study ID Numbers: CLR_10_28
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Sun Pharma Advanced Research Company Limited: