Acute Myeloid Leukaemia (AML), Advanced Solid Tumors, High-risk Myelodysplastic Syndrome
Conditions
Keywords
Relapse, Refractory, Metastatic, Advanced, Solid Tumor, AML, Myelodysplastic syndrome
Brief summary
This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study. To be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.
Detailed description
Participants may continue treatment until loss of clinical benefit as judged by the investigator, unacceptable toxicity, start of subsequent anticancer therapy, or until any other criterion for withdrawal from the treatment or the study is met.
Interventions
DRUGRVU120
RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19
DRUGRuxolitinib
Selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2
Sponsors
Ryvu Therapeutics SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles. 2. The participant is currently benefiting from, and expected to continue to benefit from, RVU120-based treatment according to the criteria set out in the parent study protocol and according to the judgment of the investigator and sponsor. 3. The participant does not have access to commercially available comparator anticancer therapy. 4. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 5. The participant signed the rollover study ICF prior to any study-related procedure or study data collection. 6. The participant agrees not to donate blood during study participation and until 28 weeks (\~6.5 months) after the last dose. 7. The investigator considers the participant to be eligible for participation in the rollover study.
Exclusion criteria
1. Presence of toxicity that cannot be adequately managed. 2. Concurrent participation in any therapeutic clinical study other than the parent study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (Safety and Tolerability) | 12 months | Number and grade of adverse events assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response | 12 months | Time from the first administration of RVU120-based treatment in the parent study until discontinuation of RVU120-based treatment for any reason in the rollover study. |
Countries
France, Poland
Outcome results
None listed