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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
AND017
DrugOral administration of AND017 capsules three times per week
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: AND017 Dose A three times weeklyExperimental treatment 1 intervention
Group B: AND017 Dose B three times weeklyExperimental treatment 1 intervention
Group C: AND017 Dose C three times weeklyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of responding patient
Responding patient is defined as those with a maximum change from baseline in hemoglobin level greater than 10% during the treatment
Time frame
From baseline to Week 6 or End of Treatment visitSecondary outcomes
1
Transfusion treatment rate
The percentage of subjects who need to receive blood transfusion during the treatment
Time frame
From baseline to Week 6 or End of Treatment visit2
Mean and change from baseline in hemoglobin levels at each study visit
Mean and change from baseline in hemoglobin levels at each study visit
Time frame
From baseline to Week 6 or End of Treatment visit3
The maximum change from baseline in hemoglobin during the treatment
The maximum change from baseline in hemoglobin during the treatment
Time frame
From baseline to Week 6 or End of Treatment visit4
Percentage of visits in which subjects maintained a hemoglobin between elevation >10% of baseline and hemoglobin<12.0 g/dL after reaching an elevation of 10% from baseline
Percentage of visits in which subjects maintained a hemoglobin between elevation \>10% of baseline and hemoglobin\<12.0 g/dL after reaching an elevation of 10% from baseline
Time frame
From baseline to Week 6 or End of Treatment visitLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: