Chemotherapy Induced AnemiaPhase 2NCT06075030
A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy
A Phase 2 study testing AND017 in people with Chemotherapy Induced Anemia, run by Kind Pharmaceuticals LLC.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Anemia
- What is being tested?
- AND017
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Dec 2027to May 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Total bilirubin <1.5 x upper limit of normal (ULN) If Gilbert's syndrome (unconjugated hyperbilirubinemia) have a total bilirubin < 3 x ULN.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN.
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- No iron deficiency, TSAT ≥ 20% and ferritin ≥ 100 ng/mL at screening.
- Serum folate and vitamin B12 ≥ lower limit of normal at screening.
- eGFR >60 mL/min/1.73 at screening.
Who cannot join
- 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.
- Active infection or inflammatory disease requiring systemic anti-infective therapy within 1 week prior to the first dose, including concurrent autoimmune diseases with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.)
- Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.)
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- Difficulty to take oral medications, or conditions that may have an impact on the absorption of gastrointestinal medications such as a history of gastrectomy/bowel resection or concomitant gastroparesis (excluding gastric polyps or colonic polypectomy).
- clinically significant bleeding (including the need for blood transfusion or a decrease in hemoglobin ≥ 2 g/dL) within 4 weeks prior to the first dose, or a bleeding constitutional or bleeding risk that has not been medically or surgically corrected.
- Uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values > 90 mmHg and/or systolic blood pressure ≥ 160 mmHg at 16 weeks prior to and including screening testing)
- Concurrent congestive heart failure (New York Heart Association [NYHA] class III or higher).
- Clinically significant ECG abnormalities at the time of screening evaluation
- Medical history of significant liver disease or active liver disease
- History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or pulmonary infarction within 24 weeks prior to the screening evaluation
- History of prior thrombosis, significant coagulation abnormalities, history of hematologic disease, or history of ineffective erythropoietin therapy
- History of epilepsy or any past seizures.
- Positive hepatitis B surface antigen (HBsAg), or positive anti-hepatitis C virus (HCV) antibodies, or positive human immunodeficiency virus HIV at screening evaluation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Open-label Study of AND017 for the Treatment of Cancer-Related Anemia Patients Receiving Chemotherapy
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.
- Conditions
- Chemotherapy Induced Anemia
- Being tested
- AND017
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AND017Drug
Oral administration of AND017 capsules three times per week
| Study group | Role | What they receive |
|---|---|---|
| AND017 Dose A three times weekly | Experimental | Not described Receives: Drug: AND017 |
| AND017 Dose B three times weekly | Experimental | Not described Receives: Drug: AND017 |
| AND017 Dose C three times weekly | Experimental | Not described Receives: Drug: AND017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to Week 6 or End of Treatment visit
Secondary outcomes (6)
Transfusion treatment rate
The percentage of subjects who need to receive blood transfusion during the treatment
Measured: From baseline to Week 6 or End of Treatment visit
Mean and change from baseline in hemoglobin levels at each study visit
Mean and change from baseline in hemoglobin levels at each study visit
Measured: From baseline to Week 6 or End of Treatment visit
The maximum change from baseline in hemoglobin during the treatment
The maximum change from baseline in hemoglobin during the treatment
Measured: From baseline to Week 6 or End of Treatment visit
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
Measured: From baseline to Week 6 or End of Treatment visit
Percentage of subjects whose hemoglobin remained between elevation >10% of baseline and hemoglobin< 12.0 g/dL after 5 weeks treatment
Percentage of subjects whose hemoglobin remained between elevation >10% of baseline and hemoglobin< 12.0 g/dL after 5 weeks treatment
Measured: At baseline and Week 6
Time for hemoglobin reaching an elevation of >10% from baseline during treatment
Time for hemoglobin reaching an elevation of >10% from baseline during treatment
Measured: From baseline to Week 6 or End of Treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study startDec 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kind Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075030
- Sponsor's protocol ID
- AND017-CRA-203
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No