NCT04500587CompletedPhase 1
Phase 1 First in Human Study of ZN-d5 as a Single Agent
Phase 1 First in Human Dose-Escalation Study of ZN-d5 as a Single Agent in Subjects With Non-Hodgkin Lymphoma or Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
Phase 1 dose escalation study of ZN-d5 in subjects with relapsed or refractory non-Hodgkin lymphoma (NHL) or acute myeloid leukemia (AML).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 30 Jul 2020
- Start date
- 13 Oct 2020
- Primary completion date
- 12 Dec 2023
- Lead sponsor
- K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT04500587
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 39
- From 13 Oct 2020 to the primary completion date, 12 Dec 2023
- 14 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent interventions including major surgery, radiation therapy, stem cell transplant.
- Treatment with anti-neoplastic agents with 5 half-lives.
- Significant unresolved toxicity from prior treatments including active GVHD.
- Prior therapy with venetoclax.
Other illness
- Active central nervous system disease.
- Clinically substantial myocardial impairment.
Who the study is looking for
- NHL: relapsed or refractory NHL including DLBCL, FL, MZL, MCL, LCL, LPL and PTC
- Subjects must have received at least 2 prior lines of therapy and have either failed or not be eligible for any available therapies expected to provide clinical benefit and have measurable disease.
- AML: Primary, secondary, or treatment-related AML, relapsed or refractory to prior therapy, which may include failure of one cycle of induction therapy.
- White blood cell count \< 25 × 109/L. Cytoreduction prior to treatment is acceptable.
- Subjects may not be pregnant and must agree to use an effective method of contraception.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Estimated life expectancy of at least 12 weeks.
- Adequate hematologic and organ function, including creatinine clearance ≥ 60 mL/min.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.