Trials / Completed
CompletedNCT02249091
A Phase II Study of Selinexor Plus Cytarabine and Idarubicin in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
An Investigator-Initiated Study To Evaluate Ara-C and Idarubicin in Combination With the Selective Inhibitor Of Nuclear Export (SINE) Selinexor (KPT-330) in Patients With Relapsed Or Refractory AML
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- GSO Global Clinical Research BV · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Acute Myeloid Leukemia (AML) is currently treated with chemotherapy by combining several drugs with different ways of inhibiting the cell growth. In this trial, standard chemotherapeutics that have proven their effectiveness for years, Ara-C and Idarubicin, will be combined with a new drug called Selinexor. Selinexor inhibits the growth of cancer cells by keeping certain proteins in the nucleus which control the cell growth.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selinexor | Patients receive Selinexor as specified in arm/group description (8 doses of 40 mg/m\^2 or 6 doses of 60 mg per induction cycle). |
| DRUG | Idarubicin | Infusion, iv, 10 mg/m\^2, on days 1,3,5 in cycle 1, on days 1,3 in cycle 2 |
| DRUG | Cytarabine | Continuous infusion day 1 to 7, 100 mg/m\^2, iv, |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2018-07-31
- Completion
- 2018-07-31
- First posted
- 2014-09-25
- Last updated
- 2021-08-25
- Results posted
- 2021-08-25
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02249091. Inclusion in this directory is not an endorsement.