Trials / Terminated
TerminatedNCT03698227
OlaReDo - Olaratumab and Rechallenge With Doxorubicin in Soft Tissue Sarcoma Patients
Efficacy of Olaratumab and Rechallenge With Doxorubicin in Anthracycline Pretreated, Advanced Soft Tissue Sarcoma Patients. An Exploratory Phase-II Study
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an exploratory, prospective, open label, single arm, phase II-study for the evaluation of efficacy and feasibility (as determined by safety and tolerability) of olaratumab and doxorubicin rechallenge in anthracycline pretreated locally advanced (unresectable) or metastatic soft tissue sarcoma patients.
Detailed description
Until now, rechallenge with anthracyclines in patients with metastatic STS which had a benefit from prior anthracycline containing therapy was never investigated in a prospective study. Due to the very promising effect of olaratumab and doxorubicin in anthracycline-naïve patients and further taking into consideration the results of the retrospective anthracycline rechallenge study, there is a clear rationale to evaluate the effects of olaratumab and doxorubicin also in anthracycline pretreated patients by conducting a prospective clinical trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olaratumab | iv infusion |
| DRUG | Dexrazoxane | iv infusion |
| DRUG | Doxorubicin | iv infusion |
Timeline
- Start date
- 2018-11-12
- Primary completion
- 2020-06-25
- Completion
- 2020-06-25
- First posted
- 2018-10-05
- Last updated
- 2020-07-15
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03698227. Inclusion in this directory is not an endorsement.