Recurrent or Metastatic Breast CancerPhase 1NCT03109249
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer
A Phase 1 study testing SPARC1613 and Reference1613 in people with Recurrent or Metastatic Breast Cancer, run by Sun Pharma Advanced Research Company Limited at 24 sites in India.
Trial summary
SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent or Metastatic Breast Cancer
- What is being tested?
- SPARC1613 and Reference1613
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 24 sitesIndia
- Study dates
- 14 Jan 2017to 4 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has given written, informed consent and is available for the duration of study
- Histologically or cytologically confirmed diagnosis of breast cancer
- Male or female aged ≥ 18 years
- Females subjects of child-bearing potential must have a negative urine pregnancy test
- Female subjects must be non-lactating and non-breastfeeding
- Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing
Who cannot join
- Known hypersensitivity to either of the study drugs or their excipients
- Inability to undergo venipuncture and/or tolerate venous access
- Pre-existing clinically significant peripheral neuropathy
- Positive laboratory exclusion test (HIV, HBsAg, or HCV)
- Treatment with investigational agents or participation in clinical trial within 30 days of study entry
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
India24 sites
SPARC Site 20
Ahmedabad, Gujarat, 380052
SPARC site 39
Ahmedabad, Gujarat, 380060
SPARC Site 13
Bangalore, Karnataka, 560027
SPARC site 41
Bangalore, Karnataka, 560072
SPARC Site 28
Bangalore, Karnataka, 560090
SPARC Site 22
Belagavi, Karnataka, 590010
SPARC site 42
Chennai, Tamil Nadu, DrGRaja
SPARC Site 25
Chhatrapati Sambhajinagar, Maharashtra, 431 003
SPARC Site 23
Chhatrapati Sambhajinagar, Maharashtra, 431210
SPARC Site 9
Chhatrapati Sambhajinagar, Marashtra, 431005
SPARC site 38
Karamsad, Gujarat, 388325
SPARC Site 15
Khordha, Odisha, 751007
SPARC Site 32
Madurai, Tamil Nadu, 625107
SPARC Site 7
Mangalore, Karnataka, 5750001
SPARC Site 2
Mumbai, Maharashtra, 400022
SPARC Site 12
Nagpur, Maharashtra, 440003
SPARC site 34
Nashik, Maharashtra, 422004
SPARC Site 37
Nashik, Maharashtra, 422005
SPARC Site 18
Pune, Maharashtra, 411 044
SPARC Site 4
Pune, Maharashtra, 411004
SPARC Site 27
Surat, Gujarat, 395002
SPARC Site 35
Surat, Gujarat, 422005
SPARC Site 24
Vadodara, Gujarat, 391760
SPARC Site 40
Visakhapatnam, Andhra Pradesh, 530017
About this study
SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.
Read the detailed description
The purpose of this study is to evaluate level of test medication with respect to time in the body, and safety when compared with the reference medication Subject will be randomly assigned to receive an intravenous infusion of either SPARC1613 delivered over 25 (±1) minutes or Reference1613 delivered over 30 (±1) minutes
- Conditions
- Recurrent or Metastatic Breast Cancer
- Being tested
- SPARC1613, Reference1613
- Medical subject headings
- Recurrence, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC1613Drug
Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)
Reference1613Drug
Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)
| Study group | Role | What they receive |
|---|---|---|
| SPARC1613 | Experimental | Intravenous administration of SPARC1613 Receives: Drug: Reference1613 |
| Reference 1613 | Active comparator | Intravenous administration of Reference1613 Receives: Drug: SPARC1613 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Pre-dose,post dose upto 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start14 Jan 2017
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic 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
- 142 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
- NCT03109249
- Sponsor's protocol ID
- CLR_16_13
- Status last verified
- May 2019
- First submitted
- 6 Apr 2017
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
- Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03109249
- Acronym / sponsor ID
- CLR_16_13
- Conditions
- Recurrent or Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2017 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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.
SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.
Detailed description
The purpose of this study is to evaluate level of test medication with respect to time in the body, and safety when compared with the reference medication Subject will be randomly assigned to receive an intravenous infusion of either SPARC1613 delivered over 25 (±1) minutes or Reference1613 delivered over 30 (±1) minutes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPARC1613 | Experimental | Drug: Reference1613Intravenous administration of SPARC1613 |
| Reference 1613 | Active comparator | Drug: SPARC1613Intravenous administration of Reference1613 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject has given written, informed consent and is available for the duration of study
- Histologically or cytologically confirmed diagnosis of breast cancer
- Male or female aged ≥ 18 years
- Females subjects of child-bearing potential must have a negative urine pregnancy test
- Female subjects must be non-lactating and non-breastfeeding
Key exclusion criteria (5 listed)
- Known hypersensitivity to either of the study drugs or their excipients
- Inability to undergo venipuncture and/or tolerate venous access
- Pre-existing clinically significant peripheral neuropathy
- Positive laboratory exclusion test (HIV, HBsAg, or HCV)
- Treatment with investigational agents or participation in clinical trial within 30 days of study entry
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 |
|---|---|---|
| SPARC1613Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2) | Drug | Reference 1613 |
| Reference1613Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2) | Drug | SPARC1613 |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Pre-dose,post dose upto 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No
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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.
24 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 SPARC1613 and Reference1613 in people with Recurrent or Metastatic Breast Cancer, run by Sun Pharma Advanced Research Company Limited at 24 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 6 inclusion and 5 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: finished, 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 24 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 upto 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.