Trials / Terminated
TerminatedNCT03614728
Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
A Phase I/II Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents in Participants With Myelodysplastic Syndrome and Acute Myeloid Leukaemia
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, tolerability, and clinical activity of GSK3326595 in participants with relapsed and refractory MDS, chronic myelomonocytic leukemia (CMML), and AML. The study will be conducted in 2 parts: Part 1 will determine the clinical benefit rate (CBR) of GSK3326595 in monotherapy and Part 2 will be expanded to study GSK3326595 in combination with 5-Azacitidine which will be composed of a dose escalation phase followed by dose expansion cohort of GSK3326595.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK3326595 | GSK3326595 will be administered. |
| DRUG | 5-Azacitidine | 5-Azacitidine will be administered. |
Timeline
- Start date
- 2018-10-16
- Primary completion
- 2022-01-11
- Completion
- 2022-01-11
- First posted
- 2018-08-03
- Last updated
- 2023-02-06
- Results posted
- 2023-02-06
Locations
8 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03614728. Inclusion in this directory is not an endorsement.