A Study of Soft Tissue Sarcoma with Olaratumab, Gemcitabine and Docetaxel
- Conditions
- soft tissue sarcomaMedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001316-34-DE
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 314
Patients at least 16 years of age, ECOG PS 0 to 1, gemcitabine and
docetaxel naïve, with histologically confirmed, locally advanced,
unresectable or metastatic STS, and not amenable to curative treatment
with surgery or radiotherapy.
The patient may have no more than 2 prior lines of systemic therapies
(neoadjuvant and adjuvant therapies will not be considered as a prior
line of therapy) for locally advanced or metastatic disease and is suitable
to receive gemcitabine and docetaxel therapy. All previous anticancer
treatments must have completed = 3 weeks (21 days) prior to first dose
of study drug.
•In the phase 2 part, prior olaratumab/doxorubicin combination therapy
in one prior treatment line is allowed.
Prior olaratumab therapy must have been received with doxorubicin as
indicated on the olaratumab label.
Prior olaratumab therapy must have included at least 2 full cycles of
olaratumab/doxorubicin (i.e. a minimum of 4 doses of olaratumab).
Patients who completed at least 2 cycles of combination
olaratumab/doxorubicin therapy then discontinued doxorubicin due to
toxicity or maximum dosing and proceeded to olaratumab monotherapy
are eligible.
The most recent dose of olaratumab must have been received within 180
days of randomization in this study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 174
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
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
- Primary Outcome Measures
Name Time Method Main Objective: Overall Survival (OS);Secondary Objective: Progression-Free Survival (PFS) ;Primary end point(s): Overall Survival;<br> Timepoint(s) of evaluation of this end point: This study will be considered complete (that is, the scientific evaluation<br> will be complete [study completion]) following final analysis of the OS<br> endpoint (<<SW>>at least 108 OS events in the olaratumab naïve arm)<br> has been performed and evaluated, as determined by Lilly (Figure<br> JGDL.3). <<JGDJ(a)>>Investigators will continue to follow the study<br> schedule for all patients until notified by Lilly that study completion has<br> occurred.<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Progression Free Survival (OS);Timepoint(s) of evaluation of this end point: Conclusion of phase II trial