A Study of Soft Tissue Sarcoma with Olaratumab, Gemcitabine and Docetaxel

Phase 1

• Conditions: soft tissue sarcoma; MedDRA version: 20.0Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001316-34-IT
• Lead Sponsor: ELI LILLY & COMPANY, LILLY CORPORATE CENTER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

Patients at least 16 years of age, ECOG PS 0 to 1, gemcitabine, docetaxel, and olaratumab naïve, with histologically confirmed, locally advanced, unresectable or metastatic STS, and not amenable to curative treatment with surgery or radiotherapy. The patient may have received at most 2 previous lines of systemic therapy (neoadjuvant and adjuvant therapies will not be considered as prior therapy) for locally advanced or metastatic disease and is suitable for receiving gentamicitabine and docetaxel therapy. antitumor should be completed more than 3 weeks (= 3 weeks (21 days)) before receiving the first dose of study medication.
In phase 2 the previous combination therapy with olaratumab / doxorubicin in a treatment line is allowed.
Previous olaratumeb therapy must have been with doxorubicin as indicated on the olaratumab label.
Prior therapy with olaratumab must have included at least 2 complete cycles of olaratumab / doxorubicin (ie a minimum of 4 doses of oloratumab).
Patients who have completed at least 2 courses of therapy with olaratumab / doxorubicin in combination and who have suspended doxorubicin due to maximum toxicity or dose and continued with olaratumab as monotherapy are still suitable. the last most recent dose of olaratumab must have been taken within 180 days of randomization in this study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 172
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Patients with gastrointestinal stromal tumor or Kaposi’s sarcoma will be excluded. Patients previously enrolled in Study I5B-MC-JGDJ or any other blinded study with olaratumab are not eligible to participate in this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified