Solid Tumor in Advanced StagePhase 1NCT01305512
Pharmacokinetic, Safety and Tolerability Study of SPARC1028
A Phase 1 study testing SPARC1028 in people with Solid Tumor in Advanced Stage, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
Trial summary
Evaluation of pharmacokinetic profile of SPARC1028 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor in Advanced Stage
- What is being tested?
- SPARC1028
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option.
- Age ≥18 years
- ECOG Performance Status ≤ 1.
- Estimated life expectancy of at least 12-weeks;
Who cannot join
- Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
- Known hypersensitivity to the study drugs
- Treatment with any anti-cancer agents within 28 days of study entry
- Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of pharmacokinetic profile of SPARC1028
Read the detailed description
This is a phase I study of SPARC1028 and recommend phase II dose of SPARC1028 administered once a week for 3 weeks, followed by 1 week of rest.
- Conditions
- Solid Tumor in Advanced Stage
- Being tested
- SPARC1028
- Keywords
- Solid, Tumor, Taxane
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC1028Drug
SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest
| Study group | Role | What they receive |
|---|---|---|
| SPARC1028 | Experimental | Not described Receives: Drug: SPARC1028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Maximum Tolerated Dose (MTD) during dose escalation
MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects
Measured: One 21-day treatment cycle
Secondary outcomes (1)
Establishing pharmacokinectic profile at each dose level for SPARC1028
Plasma levels of SPARC1028 will be determined and PK parameters viz., Cmax, AUC0-t, AUC0-∞, MRT, Tmax, t½, Kel, Vd, Cl for SPARC1028 will be evaluated
Measured: One 21-day treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startMay 2012
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor in Advanced StageStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01305512
- Sponsor's protocol ID
- CLR_10_28
- Status last verified
- May 2019
- First submitted
- 24 Feb 2011
- 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
- Pharmacokinetic, Safety and Tolerability Study of SPARC1028
- ClinicalTrials.gov ID
- NCT01305512
- Acronym / sponsor ID
- CLR_10_28
- Conditions
- Solid Tumor in Advanced Stage
- Keywords
- Solid, Tumor, Taxane
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Feb 2011 (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.
Evaluation of pharmacokinetic profile of SPARC1028
Detailed description
This is a phase I study of SPARC1028 and recommend phase II dose of SPARC1028 administered once a week for 3 weeks, followed by 1 week of rest.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPARC1028 | Experimental | Drug: SPARC1028 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option.
- Age ≥18 years
- ECOG Performance Status ≤ 1.
- Estimated life expectancy of at least 12-weeks;
Key exclusion criteria (4 listed)
- Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
- Known hypersensitivity to the study drugs
- Treatment with any anti-cancer agents within 28 days of study entry
- Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or 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 |
|---|---|---|
| SPARC1028SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest | Drug | SPARC1028 |
Primary outcome
Determination of Maximum Tolerated Dose (MTD) during dose escalation
Time frame: One 21-day treatment cycle
MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects
1 secondary outcome
Establishing pharmacokinectic profile at each dose level for SPARC1028
Time frame: One 21-day treatment cycle
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.
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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 1 study testing SPARC1028 in people with Solid Tumor in Advanced Stage, 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: 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 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 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?
Determination of Maximum Tolerated Dose (MTD) during dose escalation (time frame: One 21-day treatment cycle). 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.