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Taxane

Chemotherapy + Immunotherapy for Advanced Sarcoma

Q: What other investigative efforts have been made concerning Gemcitabine?

Currently, 1703 clinical trials of Gemcitabine are still underway with 416 being in the final phase. Most studies involving this drug are centred around Shanghai but 95279 locations across the world have been identified as research hubs for Gemcitabine.

Q: Is this trial novel in relation to similar research?

Alfacell's 1997 trial initiation for Gemcitabine has evolved into a total of 1703 active studies across 86 countries. Since the initial study, which involved 300 participants and concluded with Phase 3 approval, 2440 other trials have been successfully completed.

Q: Is this research still enrolling participants?

Per the clinicaltrials.gov listing, this medical trial has been open for recruitment since September 30th 2020 and was recently modified on May 4th 2022.

Q: Has the FDA given their seal of approval to utilizing Gemcitabine?

There is some evidence of Gemcitabine's safety but no clinical data backing its efficacy, so it was assigned a rating of 2.

Q: To what ailments is Gemcitabine commonly prescribed?

Gemcitabine is the medication of choice for treating <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a> (<a href="https://www.withpower.com/clinical-trials/all">ALL</a>) and has been proven to be effective in managing head, metastatic ureter urothelial carcinoma, as well as metastatic <a href="https://www.withpower.com/clinical-trials/hepatocellular-carcinoma">hepatocellular carcinoma</a>.

Q: What is the upper capacity of participants for this experiment?

Affirmative. According to the information found on clinicaltrials.gov, this medical trial is actively recruiting patients as of May 4th 2022. The study started being advertised on September 30th 2020 and requires a total of 260 participants from one site location.

Phase 2

Recruiting

Led By Sant P Chawla, MD

Research Sponsored by Sarcoma Oncology Research Center, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat advanced sarcoma.

Who is the study for?

This trial is for adults with advanced sarcoma that's inoperable or has spread, who understand the study and agree to follow its procedures. They must have had prior treatment, be reasonably healthy (ECOG ≤ 2), not on certain blood thinners, and have good organ function. Women of childbearing age need a negative pregnancy test and must use effective contraception.Check my eligibility

What is being tested?

The GALLANT trial tests low-dose chemotherapy drugs Gemcitabine, Doxorubicin, Docetaxel combined with Nivolumab immunotherapy in patients with advanced sarcoma. It's an open-label phase 2 study where all participants receive the same treatment intravenously.See study design

What are the potential side effects?

Possible side effects include fatigue, nausea, hair loss from chemotherapy drugs; immune-related issues like inflammation of organs can occur due to Nivolumab. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My sarcoma cannot be surgically removed and has spread.

Select...

My blood clotting tests are normal or managed if I'm on blood thinners.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My cancer can be measured by standard imaging tests.

Select...

I am not pregnant and agree to use effective birth control during and after the study.

Select...

My heart pumps blood well, with an ejection fraction over 50%.

Select...

My kidney function is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival

Secondary outcome measures

Adverse Events

Overall response

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single armExperimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

Doxorubicin

2012

Completed Phase 3

~7940

Docetaxel

1995

Completed Phase 4

~5620

Nivolumab

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sarcoma Oncology Research Center, LLCLead Sponsor

7 Previous Clinical Trials

306 Total Patients Enrolled

6 Trials studying Sarcoma

226 Patients Enrolled for Sarcoma

Sant P Chawla, MDPrincipal InvestigatorSarcoma Oncology Research Center, LLC

6 Previous Clinical Trials

224 Total Patients Enrolled

4 Trials studying Sarcoma

144 Patients Enrolled for Sarcoma

Media Library

Docetaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT04535713 — Phase 2

Sarcoma Research Study Groups: Single arm

Sarcoma Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04535713 — Phase 2

Docetaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04535713 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other investigative efforts have been made concerning Gemcitabine?

"Currently, 1703 clinical trials of Gemcitabine are still underway with 416 being in the final phase. Most studies involving this drug are centred around Shanghai but 95279 locations across the world have been identified as research hubs for Gemcitabine."

Answered by AI

Is this trial novel in relation to similar research?

"Alfacell's 1997 trial initiation for Gemcitabine has evolved into a total of 1703 active studies across 86 countries. Since the initial study, which involved 300 participants and concluded with Phase 3 approval, 2440 other trials have been successfully completed."

Answered by AI

Is this research still enrolling participants?

"Per the clinicaltrials.gov listing, this medical trial has been open for recruitment since September 30th 2020 and was recently modified on May 4th 2022."

Answered by AI

Has the FDA given their seal of approval to utilizing Gemcitabine?

"There is some evidence of Gemcitabine's safety but no clinical data backing its efficacy, so it was assigned a rating of 2."

Answered by AI

To what ailments is Gemcitabine commonly prescribed?

"Gemcitabine is the medication of choice for treating acute lymphoblastic leukemia (ALL) and has been proven to be effective in managing head, metastatic ureter urothelial carcinoma, as well as metastatic hepatocellular carcinoma."

Answered by AI

What is the upper capacity of participants for this experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is actively recruiting patients as of May 4th 2022. The study started being advertised on September 30th 2020 and requires a total of 260 participants from one site location."

Answered by AI

Recent research and studies

Advances in TherapyJournal

Trabectedin for Soft Tissue Sarcoma: Current Status and Future Perspectives

Gordon, Erlinda M., K. Kumar Sankhala, Neal Chawla, and Sant P. Chawla. 2016. “Trabectedin for Soft Tissue Sarcoma: Current Status and Future Perspectives”. Advances in Therapy. Springer Science and Business Media LLC. doi:10.1007/s12325-016-0344-3.

Advances in TherapyJournal

Trabectedin for Soft Tissue Sarcoma: Current Status and Future Perspectives

Molecular Cancer TherapeuticsJournal

A Review of Trabectedin (ET-743): A Unique Mechanism of Action

D'Incalci, Maurizio, and Carlos M. Galmarini. 2010. “A Review of Trabectedin (ET-743): A Unique Mechanism of Action”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-10-0263.

clinicaltrials.govStudy

GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma