Multiple MyelomaPhase 1NCT00863174
A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma
A Phase 1 study testing SPARC147709 and Reference147709 in people with Multiple Myeloma, run by Sun Pharma Advanced Research Company Limited.
Trial summary
Safety and bioequivalence of SPARC_147709 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- SPARC147709 and Reference147709
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Apr 2011
- 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
- Availability for the entire study period and willingness to adhere to protocol requirements.
- Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome
- 18 years of age or older
- No evidence of underlying disease (except multiple myeloma)
Who cannot join
- History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride
- History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
- History of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
- Positive result to HIV, HCV, RPR and HBsAg.
About this study
Official title: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of SPARC_147709- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma
Safety and bioequivalence of SPARC_147709
- Conditions
- Multiple Myeloma
- Being tested
- SPARC147709, Reference147709
- Keywords
- Multiple myeloma, Bio-equivalence
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC147709Drug
SPARC147709 injection
Reference147709Drug
Reference147709 injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SPARC147709 Receives: Drug: SPARC147709 |
| 2 | Active comparator | Reference147709 Receives: Drug: Reference147709 |
What is being measured
The primary outcome is the main question the study is designed to answer.
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference
Measured: 2 cycles
Secondary outcomes (1)
Treatment Emergent Adverse Events
Measured: 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startNov 2010
- Primary completionJan 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT00863174
- Sponsor's protocol ID
- DOX_21_1477_09
- Status last verified
- May 2019
- First submitted
- 16 Mar 2009
- 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
- A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of SPARC_147709- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00863174
- Acronym / sponsor ID
- DOX_21_1477_09
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Bio-equivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Mar 2009 (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.
Safety and bioequivalence of SPARC_147709
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SPARC147709SPARC147709 |
| 2 | Active comparator | Drug: Reference147709Reference147709 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Availability for the entire study period and willingness to adhere to protocol requirements.
- Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome
- 18 years of age or older
- No evidence of underlying disease (except multiple myeloma)
Key exclusion criteria (4 listed)
- History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride
- History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
- History of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
- Positive result to HIV, HCV, RPR and HBsAg.
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 |
|---|---|---|
| SPARC147709SPARC147709 injection | Drug | 1 |
| Reference147709Reference147709 injection | Drug | 2 |
Primary outcome
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference
Time frame: 2 cycles
1 secondary outcome
Treatment Emergent Adverse Events
Time frame: 2 cycles
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPARC147709 and Reference147709 in people with Multiple Myeloma, run by Sun Pharma Advanced Research Company Limited.
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.
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?
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference (time frame: 2 cycles). 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.