Description:
This is an open label phase 2 study for advanced sarcoma using metronomic doses of
gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.
Title
- Brief Title: GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
- Official Title: GALLANT: A Phase 2 Study Using Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab as Second/Third Line Therapy for Advanced Sarcoma
Clinical Trial IDs
- ORG STUDY ID:
SOC-2082
- NCT ID:
NCT04535713
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Gemcitabine | Gemzar | Single arm |
Doxorubicin | Adriamycin | Single arm |
Docetaxel | Taxotere | Single arm |
Nivolumab | Opdivo | Single arm |
Purpose
This is an open label phase 2 study for advanced sarcoma using metronomic doses of
gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.
Detailed Description
This is an open label phase 2 study for advanced sarcoma using metronomic doses of
gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously.
A total of 260 patients will receive gemcitabine 600 mg/m2 (maximum dose: 1000 mg) on D1 and
D8, doxorubicin 18 mg/m2 on D1 and D8 (maximum dose: 32 mg), docetaxel 25 mg/m2 on D1 and D8
(maximum dose: 42 mg), on Days 1 and 8. After the first cycle, nivolumab 240 mg IV will be
added on Day 1 of each cycle (see product information; www.accessdata.fda.gov). Treatment
cycles are given every 3 weeks. Patients in this study may continue treatment until
significant disease progression or unacceptable toxicity occurs up to one year of therapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Single arm | Experimental | A total of 260 patients will receive gemcitabine 600 mg/m2 (maximum dose: 1000 mg) on D1 and D8, doxorubicin 18 mg/m2 on D1 and D8 (maximum dose: 32 mg), docetaxel 25 mg/m2 on D1 and D8 (maximum dose: 42 mg), on Days 1 and 8. After the first cycle, nivolumab 240 mg IV will be added on Day 1 of each cycle (see product information; www.accessdata.fda.gov). Treatment cycles are given every 3 weeks. Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy. Patients who withdraw or do not complete the first 2 treatment cycles and first follow up CT scan/MRI will be replaced. | - Gemcitabine
- Doxorubicin
- Docetaxel
- Nivolumab
|
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic
sarcoma
- Ability to understand the purposes and risks of the study and has signed and dated a
written informed consent form approved by the Investigator's IRB/Ethics Committee
- Willingness to comply with all study procedures and availability for the duration of
the study.
- Previously treated patient with measurable disease by RECIST v1.1
- ECOG performance status ≤ 2
- Life expectancy of at least 3 months
- Acceptable cardiac function with LV ejection fraction of > 50%
- Acceptable liver function: Bilirubin < 1.5 times upper limit of normal (ULN; except
subjects with Gilbert Syndrome who must have a total bilirubin level < 3.0 ULN); AST
(SGOT), ALT (SGPT) and alk phos < 2.5 x ULN (< 5 x ULN if liver metastases present)
- Acceptable renal function: Creatinine < 1.5 times ULN and creatinine clearance > 60
ml/min using the Crockroft-Gault formula
- Acceptable hematologic status: ANC >1000 cells/μL; Platelet count >100,000/μL;
Hemoglobin > 9.0 g/dL
- INR and PT < 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT
must be within therapeutic range of intended use of anticoagulants
- All women of childbearing potential must have a negative urine or serum pregnancy test
within 72 hours of enrollment. If urine test is positive or cannot be confirmed as
negative, a serum pregnancy test will be required; all subjects must agree to use
highly effective means of contraception (surgical sterilization or the use of barrier
contraception with either a condom or diaphragm in conjunction with spermicidal gel or
an IUD) with their partner from entry into the study through 5 months for women and 7
months for men after the last dose.
Exclusion Criteria:
- History or evidence of active autoimmune disease that requires systemic treatment (ie,
with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of
systemic treatment.
- Currently receiving treatment with another investigational device or drug study, or
<14 days since ending treatment with another investigational device or drug study(s).
- Subject has known sensitivity to gemcitabine, doxorubicin, docetaxel or nivolumab.
- Female subject is pregnant or breast-feeding or planning to become pregnant during
study treatment and through 3 months after the last dose of gemcitabine, doxorubicin,
docetaxel or nivolumab.
- Female subject of childbearing potential who is unwilling to use acceptable method(s)
of effective contraception during study treatment and through 3 months after the last
dose of gemcitabine, doxorubicin, docetaxel or nivolumab.
- Sexually active subjects and their partners unwilling to use male or female latex
condom
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression free survival |
Time Frame: | 12 months |
Safety Issue: | |
Description: | Progression free survival from start of treatment to disease progression or death from any cause |
Secondary Outcome Measures
Measure: | Overall response |
Time Frame: | 6 weeks |
Safety Issue: | |
Description: | Overall response by RECIST v1.1 via CT scan or MRI during the treatment period |
Measure: | Adverse Events |
Time Frame: | 12 months |
Safety Issue: | |
Description: | Incidence of treatment related adverse events |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Sarcoma Oncology Research Center, LLC |
Last Updated
May 10, 2021