Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/30/2019 |
| Start Date: | February 27, 2018 |
| End Date: | January 10, 2019 |
Follow up Protocol to the Open Label Phase I/II Study OPN-305-106: A Prospective, Open Label Phase I/II Study to Assess the Safety and Efficacy of Cycles of Intravenously Infused Doses of OPN-305 in Second-line and Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)
This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy
treatment or combination treatment with azacitidine after completion of the dose confirming,
dose expansion and HMA naïve parts of the main study OPN-305-106.
treatment or combination treatment with azacitidine after completion of the dose confirming,
dose expansion and HMA naïve parts of the main study OPN-305-106.
Inclusion Criteria:
- Completion of the OPN-305-106 study
- Principal Investigator adjudicated efficacy response defined as either transfusion
independence", "stable disease", "minor HI-E response" or "major HI-E response" and in
the opinion of the Principal Investigator the patient may benefit from continued
treatment with OPN-305 monotherapy or combination treatment with azacitidine.
- Provide written informed consent for the follow up protocol.
Exclusion Criteria:
- Refusal to provide written informed consent
- Withdrawal from the OPN-305-106 study prior to the final EOT visit
- Plan to be included into another interventional investigational study.
- Progression of disease
We found this trial at
1
site
Click here to add this to my saved trials
