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A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507

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ClinicalTrials.gov Identifier: NCT02597465
Recruitment Status : Not yet recruiting
First Posted : November 5, 2015
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Study Description
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Brief Summary:
An open label study to determine the efficacy and safety of SPARC1507

Condition or disease Intervention/treatment Phase
Advanced Biliary Tract Cancer Drug: SPARC1507 Drug: Reference1507 Phase 3

Detailed Description:
Subjects with advanced Biliary tract carcinoma meeting the eligibility criteria will be randomized in this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 in Subjects With Cancer
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : December 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SPARC1507
SPARC1507
 Drug: SPARC1507
The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle
Experimental: Chemotherapy
Chemotherapy
 Drug: Reference1507
Investigators choice including chemotherapy or supportive therapy


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: 3 years and 6 months ]

Secondary Outcome Measures :
  1. Overall survival in subjects treated with SPARC1507 versus Investigators choice [ Time Frame: 3 years and 6 months ]
  2. Overall response rate in subjects treated with PICN versus Investigators choice [ Time Frame: 3 years and 6 months ]
  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 3 years and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of advanced/metastatic biliary tract cancer
  • Male or female ≥ 18 years old
  • Participants must have measurable disease according to RECIST
  • ECOG performance status ≤ 1

Exclusion Criteria:

  • Known hypersensitivity to trial treatments, or their excipients
  • Prior history of treatment with any taxane therapy
  • Cardiovascular disorders as per Investigator's discretion
  • The subject has received radiation therapy
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02597465


Contacts
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Contact: Sun Pharma Advanced Research Company Limited +9122 66455645 clinical.trials@sparcmail.com

Locations
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United States, Colorado
SPARC study site Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Lindsey Davis, MD         
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
More Information
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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02597465     History of Changes
Other Study ID Numbers: CLR_15_07
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Biliary Tract Diseases
Digestive System Diseases