Solid Tumor in Advanced StagePhase 1NCT01304303
Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination
A Phase 1 study testing SPARC1023 I and SPARC1023 II in people with Solid Tumor in Advanced Stage, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
Trial summary
Phase I study of SPARC1023 alone and in combination with carboplatin 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?
- SPARC1023 I and SPARC1023 II
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 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
- Age ≥18 years
- ECOG Performance Status ≤ 1.
- Estimated life expectancy of at least 12-weeks;
- Measurable disease as per RECIST guideline (Version 1.1);
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
Phase I study of SPARC1023 alone and in combination with carboplatin
Read the detailed description
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.
- Conditions
- Solid Tumor in Advanced Stage
- Being tested
- SPARC1023 I, SPARC1023 II
- Keywords
- solid, tumor, taxane, platinum
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC1023 IDrug
IV administration
SPARC1023 IIDrug
IV administration
| Study group | Role | What they receive |
|---|---|---|
| SPARC1023 I | Experimental | Not described Receives: Drug: SPARC1023 I |
| SPARC1023 II | Experimental | Not described Receives: Drug: SPARC1023 II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of MTD
MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 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 the pharmacokinetic profile
Plasma levels of SPARC1023 and Carboplatin will be determined and PK parameters viz. Cmax, AUC0-t, AUC 0-∞, MRT, Tmax, t½ , Kel, Vd for SPARC1023 in combination with carboplatin 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 posted25 Feb 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2016
- Study completionOct 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 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
- NCT01304303
- Sponsor's protocol ID
- CLR_10_23
- Status last verified
- May 2019
- First submitted
- 23 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 and Safety Study of SPARC1023 Alone and in Carboplatin Combination
- ClinicalTrials.gov ID
- NCT01304303
- Acronym / sponsor ID
- CLR_10_23
- Conditions
- Solid Tumor in Advanced Stage
- Keywords
- solid, tumor, taxane, platinum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 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.
Phase I study of SPARC1023 alone and in combination with carboplatin
Detailed description
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPARC1023 I | Experimental | Drug: SPARC1023 I |
| SPARC1023 II | Experimental | Drug: SPARC1023 II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- ECOG Performance Status ≤ 1.
- Estimated life expectancy of at least 12-weeks;
- Measurable disease as per RECIST guideline (Version 1.1);
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 |
|---|---|---|
| SPARC1023 IIV administration | Drug | SPARC1023 I |
| SPARC1023 IIIV administration | Drug | SPARC1023 II |
Primary outcome
Determination of MTD
Time frame: One 21-day treatment cycle
MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.
1 secondary outcome
Establishing the pharmacokinetic profile
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 SPARC1023 I and SPARC1023 II 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 MTD (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.