TANGENT: Emactuzumab in Tenosynovial Giant Cell Tumors
Treatment of Emactuzumab in Tenosynovial Giant Cell Tumors (TANGENT)
| Agents: | Emactuzumab |
| Phase | III |
| Status | Open, recruiting |
| Sponsor | SynOx Therapeutics |
For further information please also consult ClinicalTrials.gov.
This is a multicenter, phase 3, randomised, double-blind, placebo-controlled study, which aims to evaluate the efficacy and safety of emactuzumab for the treatment of patients with Tenosynovial Giant Cell Tumor (TGCT).
WHO is the trial for? |
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WHAT is the key question that this trial is attempting to answer? |
The goal of this clinical trial is to assess the efficacy and safety of emactuzumab in patients with TGCT.
The study aims to assess whether emactuzumab helps tumors shrink in size or disappear and whether it improves joint movement and reduces joint pain and stiffness, compared to placebo. |
WHY patients might want to participate? |
Participation in this clinical trial provides patients with the opportunity to potentially benefit from a novel treatment, contribute to medical research, and play a role in advancing the understanding of emactuzumab in the context of TGCT. |
WHEN will the trial be open? |
This study is open for patient recruitment. |
WHERE is the trial available? |
The trial is being conducted in Spain, Italy, France, Belgium, Netherlands, Sweden, Switzerland, Taiwan, UK, the US and Canada. Further sites are planned to open soon.
For further information please check here. |
STUDY DESIGN: What does the study look like? |
The study has two main parts:
Part 1: Participants who qualify will be randomly placed into one of two groups in a 2:1 ratio. One group will receive the study drug, emactuzumab, while the other will receive a placebo (a substance with no active drug). Neither the participants nor the researchers will know which group they are in during this phase (double-blind). The treatment will involve five intravenous (IV) infusions, given once every two weeks, over a total of 10 weeks. After that, there will be a three-month observation period, making Part 1 last about 24 weeks in total. Part 2: This is a longer follow-up phase. Participants who received the placebo in Part 1 may be eligible to switch to the active study drug, emactuzumab, if they meet certain conditions. Those who received emactuzumab in Part 1 may also have the option to receive additional treatment later under specific circumstances. |
HOW do I get more information? |
ClinicalTrials.gov, cancer societies or cancer focused patient advocacy groups in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations that might be helpful. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org |
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.