A Study of AND017 to Treat Cancer Related Anemia in Patients Not Receiving Chemotherapy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKind Pharmaceuticals LLC

About this trial

The purpose of this study is to determine the safety and efficacy of various doses of AND017 after 6 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

Eligibility criteria

Qualifiers

Non-myeloid malignancy diagnosed by cytology/histology.

ECOG score 0-2 and expected survival of 6 months or more.

The mean value of hemoglobin at screening test and one follow-up test (more than one week between tests) was <10.0 g/dL, with a difference of ≤1.0 g/dL between the two tests.

Adequate hepatic and renal function.

Disqualifiers

Received chemotherapy, radiotherapy, and other, e.g., immunosuppressive, targeted drug therapy that has a suppressive effect on the bone marrow within 1 month prior to randomization or planned during the trial.

A medical history of significant liver disease or active liver disease.

A previous history of pure red blood cell remittance

A combination of hereditary anemia, iron-granulocytic anemia, acute blood loss, active bleeding (three consecutive positive fecal occult bloods or clinical judgment of the investigator), hemolysis and other conditions that can cause anemia such as iron, folic acid or vitamin B12 deficiency

Trial design

Treatments tested in this trial

  • AND017

Treatment groups

36 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators