Health TrialsbyHealthPanel

Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma

ConditionNeoplasms of Connective and Soft Tissue With an Unspecified Anatomical Site
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorYonsei University

About this trial

Arm1- bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion.

Arm2- On Day 1 of each 21-day cycle, gemcitabine will be administered first, followed by docetaxel as an intravenous infusion. On Day 8, gemcitabine and docetaxel will be administered as intravenous infusions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed advanced leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), liposarcoma, or angiosarcoma with 1-2 prior chemotherapy

Age ≥19 years, <80 years

ECOG performance status of 0-1

Has at least 1 measurable lesion (as defined by RECIST v1.1).

Disqualifiers

Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study

More than 3 prior cytotoxic agents

previously received treatment with bevacizumab, gemcitabine, or docetaxel

Unresolved toxicities from prior anticancer therapy ≥ Grade 2 according to NCI CTCAE, excluding alopecia, vitiligo, and laboratory abnormalities defined in the inclusion criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bev + Gem + Doc

    Drug

    bevacizumab (Onbevzi) at a dose of 15 mg/kg administered as a 30-minute intravenous infusion on Day 1 of each 21-day cycle, followed by intravenous infusion of gemcitabine and docetaxel in sequence. On Day 8 of each cycle, gemcitabine and docetaxel will be administered as a 60-minute intravenous infusion.

  • Gem + Doc

    Drug

    * Gemcitabine 1,000 mg/m² IV on Days 1 and 8 of each 21-day cycle (administered over 30 minutes) * Docetaxel 35 mg/m² IV on Days 1 and 8 of each 21-day cycle (administered over 60 minutes) On Day 1 of each 21-day cycle, gemcitabine will be administered first, followed by docetaxel as an intravenous infusion. On Day 8, gemcitabine and docetaxel will be administered as intravenous infusions.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Bev + Gem + DocExperimental treatment 1 intervention
Group B: Gem + DocActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate, ORR

Overall response rate (ORR) based on RECIST version 1.1

Time frame
2 year

Secondary outcomes

1

Progression-free survival (PFS)

The earlier of the date of first documented progressive disease or death from the date of enrollment

Time frame
2 year
2

Overall survival (OS)

From the date of treatment initiation to the date of death or last follow-up

Time frame
2 year
3

Safety profile

Safety profile assessed using CTCAE (version 5.0)

Time frame
2 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: