A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
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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. |
ClinicalTrials.gov Identifier: NCT02597465 |
Recruitment Status :
Withdrawn
(Sponsor decided not to initiate the study for alternate commercial strategy)
First Posted : November 5, 2015
Last Update Posted : December 14, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Biliary Tract Cancer | Drug: SPARC1507 Drug: Reference1507 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Colorado | |
SPARC study site | |
Aurora, Colorado, United States, 80045 |
Responsible Party: | Sun Pharma Advanced Research Company Limited |
ClinicalTrials.gov Identifier: | NCT02597465 |
Other Study ID Numbers: |
CLR_15_07 |
First Posted: | November 5, 2015 Key Record Dates |
Last Update Posted: | December 14, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Biliary Tract Diseases Digestive System Diseases |