A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy
ConditionChemotherapy Induced Anemia
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 AND017 after 6 weeks of treatment in patients with cancer-related anemia who are receiving chemotherapy.
Eligibility criteria
Qualifiers
Non-myeloid malignancy diagnosed by cytology/histology
Receiving and have received at least one cycle of drug therapy with a high myelosuppressive adverse effect, including but not limited to chemotherapeutic agents such as platinum, targeted agents, antibody-coupled drugs, immunosuppressive agents, etc., and are expected to continue such therapy within 8 weeks of enrollment
ECOG score of 0-2 and an expected survival of 6 months or more.
Mean hemoglobin <10.0 g/dL at screening test and one follow-up test (at least one week thereafter during the screening period), with a difference between the two tests of ≤1.0 g/dL
Disqualifiers
Hematocrit (Hct) ≥ 36 vol% at the screening assessment.
Prior history of leukemia.
Extensive bone metastases from breast cancer, head and neck cancer with combined whole blood (trilineage) cytopenia, bone marrow invasion from lymphoma, definite brain metastases (except for those whose symptoms have been controlled for ≥4 weeks) or bone marrow metastases.
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 diseases 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 groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov