Advanced Biliary Tract CancerPhase 3NCT02597465
A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507
A Phase 3 study testing SPARC1507 and Reference1507 in people with Advanced Biliary Tract Cancer, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
Trial summary
An open label study to determine the efficacy and safety of SPARC1507 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Biliary Tract Cancer
- What is being tested?
- SPARC1507 and Reference1507
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 1 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 in Subjects With Cancer
An open label study to determine the efficacy and safety of SPARC1507
Read the detailed description
Subjects with advanced Biliary tract carcinoma meeting the eligibility criteria will be randomized in this study.
- Conditions
- Advanced Biliary Tract Cancer
- Being tested
- SPARC1507, Reference1507
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC1507Drug
The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle
Reference1507Drug
Investigators choice including chemotherapy or supportive therapy
| Study group | Role | What they receive |
|---|---|---|
| SPARC1507 | Experimental | SPARC1507 Receives: Drug: SPARC1507 |
| Chemotherapy | Experimental | Chemotherapy Receives: Drug: Reference1507 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) of subjects treated with SPARC1507 versus IC, per Response Evaluation Criteria in Solid Tumors version 1.1
Measured: 3 years and 6 months
Secondary outcomes (3)
Overall survival in subjects treated with SPARC1507 versus Investigators choice
Measured: 3 years and 6 months
Overall response rate in subjects treated with PICN versus Investigators choice
Measured: 3 years and 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 3 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start1 Dec 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Why it stopped: Sponsor decided not to initiate the study for alternate commercial strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597465
- Sponsor's protocol ID
- CLR_15_07
- Status last verified
- Dec 2020
- First submitted
- 3 Nov 2015
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 in Subjects With Cancer
- ClinicalTrials.gov ID
- NCT02597465
- Acronym / sponsor ID
- CLR_15_07
- Conditions
- Advanced Biliary Tract Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided not to initiate the study for alternate commercial strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label study to determine the efficacy and safety of SPARC1507
Detailed description
Subjects with advanced Biliary tract carcinoma meeting the eligibility criteria will be randomized in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPARC1507 | Experimental | Drug: SPARC1507SPARC1507 |
| Chemotherapy | Experimental | Drug: Reference1507Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARC1507The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle | Drug | SPARC1507 |
| Reference1507Investigators choice including chemotherapy or supportive therapy | Drug | Chemotherapy |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPARC1507 and Reference1507 in people with Advanced Biliary Tract Cancer, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.