Phase 2
N=101
A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma
Sarcoma, Soft Tissue
Bottom Line
View on ClinicalTrials.gov: NCT00490451 ↗Enrolled (actual)
101
Serious AEs
32.7%
Results posted
May 2018
Primary outcome: Primary: Progression-Free Survival — 2.64; 1.38 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY573636-sodium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival |
2.64; 1.38 | — |
| SECONDARY Percentage of Participants With Complete Response or Partial Response (Objective Response Rate) |
0.0; 0.0; 3.2; 2.6 | — |
| SECONDARY Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate) |
46.0; 26.3 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 |
386.0; 325.7; 346.5; 351.8 | — |
| SECONDARY Overall Survival Time |
8.71; 12.25 | — |
| SECONDARY Duration of Overall Objective Response |
— | — |
| SECONDARY Duration of Stable Disease (SD) |
4.44; 5.91 | — |
| SECONDARY Number of Participants With Adverse Events (Safety) |
23; 10; 59; 36 | — |
Summary
The primary purpose of the study is to estimate the time from the first dose of LY573636-sodium (hereafter referred to as LY573636) to the date your physician determines that your disease has progressed or worsened.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of soft tissue sarcoma that is unresectable or metastatic
- Have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin).
- Must have stopped all previous treatments for cancer, including chemotherapy, radiation therapy or other investigational treatments for cancer for at least 30 days
Exclusion Criteria
- Participants with primary bone sarcoma (for example osteosarcoma, Ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (GIST) and Kaposi's sarcoma
- Serious pre-existing medical problems (as determined by your doctor)
- Have received more than two previous systemic treatment regimens for unresectable or metastatic soft tissue sarcoma
- Have a second primary cancer (unless cancer-free for more than 2 years)
- Active treatment with Warfarin (Coumadin)
Data sourced from ClinicalTrials.gov (NCT00490451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.