Clinical trial · Interventional
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
A Phase 1b/2 Study of AMG 655 in Combination With Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
NCT00626704CI-TRIAL-00018023completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 655 | Drug | Conatumumab | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- AMG 655 + Doxorubicin
- interventionNames
- Drug: AMG 655
- Drug: Doxorubicin
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- Placebo + Doxorubicin
- interventionNames
- Other: Placebo
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Progression-Free Survival
- timeFrame
- Length of Study
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed soft tissue sarcoma * Locally advanced, recurrent, or metastatic, unresectable disease * Measurable disease according to modified RECIST * ECOG performance status of 0 or 1 * Men or women at least 18 years of age * Adequate hematological, renal, hepatic, and coagulation function Exclusion Criteria: * Prior treatment with anthracyclines * Uncontrolled cardiovascular disease
References
Publications (0)
Data not yet available
No reference posted for this study.