Breast CancerPhase 1NCT02136927
Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
A Phase 1 study testing SPARC1210 and Reference1210 in people with Breast Cancer, run by Sun Pharma Advanced Research Company Limited at 12 sites in India.
Trial summary
Pharmacokinetic, bioequivalence study Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SPARC1210 and Reference1210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 12 sitesIndia
- Study dates
- Aug 2014to Apr 2016
- Phase
- Phase 1
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has given written, informed consent and is available for the entire study.
- Histologically or cytologically confirmed diagnosis of breast cancer;
- Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
- Age 18 years or more
Who cannot join
- Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
- Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
- Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
- Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
SPARC Site 10
Chennai, Tamil Nadu
SPARC Site 2
Goraj, Gujarat
SPARC Site 12
Hyderabad, Andhra Pradesh
SPARC Site 9
Hyderabad, Andhra Pradesh
SPARC Site 8
Kochi, Kerala
SPARC Site 7
Madurai, Tamil Nadu
SPARC Site 11
Mumbai, Maharashtra
SPARC Site 5
Nagpur, Maharashtra
SPARC Site 4
Nashik, Maharashtra
SPARC Site 6
New Delhi, National Capital Territory of Delhi
SPARC Site 1
Pune, Maharashtra
SPARC Site 3
Pune, Maharashtra
About this study
Pharmacokinetic, bioequivalence study
- Conditions
- Breast Cancer
- Being tested
- SPARC1210, Reference1210
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC1210Drug
Reference1210Drug
| Study group | Role | What they receive |
|---|---|---|
| SPARC1210 | Experimental | Intravenous administration of SPARC1210 Receives: Drug: SPARC1210 |
| Reference1210 | Active comparator | Intravenous administration of Reference1210 Receives: Drug: Reference1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.
Measured: Pre-dose, post-dose up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT02136927
- Sponsor's protocol ID
- CLR_12_10
- Status last verified
- May 2019
- First submitted
- 9 May 2014
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02136927
- Acronym / sponsor ID
- CLR_12_10
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 May 2014 (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.
Pharmacokinetic, bioequivalence study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPARC1210 | Experimental | Drug: SPARC1210Intravenous administration of SPARC1210 |
| Reference1210 | Active comparator | Drug: Reference1210Intravenous administration of Reference1210 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject has given written, informed consent and is available for the entire study.
- Histologically or cytologically confirmed diagnosis of breast cancer;
- Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
- Age 18 years or more
Key exclusion criteria (4 listed)
- Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
- Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
- Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
- Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study
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 |
|---|---|---|
| SPARC1210 | Drug | SPARC1210 |
| Reference1210 | Drug | Reference1210 |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Pre-dose, post-dose up to 3 days
Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPARC1210 and Reference1210 in people with Breast Cancer, run by Sun Pharma Advanced Research Company Limited at 12 sites in India.
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: stopped early, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early. Results are not available in the source record.
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?
Maximum observed concentration (Cmax) (time frame: Pre-dose, post-dose up to 3 days). 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 3 May 2019.