A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma
- Registration Number
- NCT00863174
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
Safety and bioequivalence of SPARC_147709
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 SPARC147709 SPARC147709 2 Reference147709 Reference147709
- Primary Outcome Measures
Name Time Method 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference 2 cycles
- Secondary Outcome Measures
Name Time Method Treatment Emergent Adverse Events 2 cycles
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular targets of SPARC_147709 in multiple myeloma treatment?
How does SPARC_147709 compare to standard-of-care proteasome inhibitors in multiple myeloma?
What biomarkers correlate with bioequivalence outcomes in NCT00863174 myeloma trial?
What adverse events are associated with SPARC_147709 in phase 1 multiple myeloma studies?
Are there combination therapies involving SPARC_147709 and other myeloma drugs under investigation?