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Compares treatment options for Patients With Chemotherapy-Induced Thrombocytopenia
Official title A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
ClinicalTrials.gov ID: NCT07286032
What this study is testing
What is Hetrombopag Olamine?
Hetrombopag Olamine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for patients with chemotherapy-induced thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female gender, age ≥18 years at screening.
- Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic...
- Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Life expectancy ≥6 months.
You likely can't join if
- Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
- Hematologic malignancies.
- Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and...
- Untreated brain metastases; or with leptomeningeal metastasis.
- Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
- Severe cardiovascular disorders or interventions within 6 months
See the full eligibility criteria
- Male or female gender, age ≥18 years at screening.
- Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
- Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Life expectancy ≥6 months.
- Signed ICF for voluntary participation in the study and good compliance.
- Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
- Hematologic malignancies.
- Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
- Untreated brain metastases; or with leptomeningeal metastasis.
- Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
- Severe cardiovascular disorders or interventions within 6 months
- Have arterial/venous thrombosis within 6 months
- Known bleeding disorders, platelet dysfunction
- Severe haemorrhage during screening
- Acute or uncontrolled hepatitis B\&C infection
- Human immunodeficiency virus (HIV) infection.
The study team makes the final eligibility decision.
Where it's taking place
- Los Alamitos, California, United States
- Denver, Colorado, United States
- Coral Springs, Florida, United States
- Orange City, Florida, United States
- Springfield, Illinois, United States
- Morristown, New Jersey, United States
- Shirley, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Alamitos, California, United States; Denver, Colorado, United States; Coral Springs, Florida, United States; Orange City, Florida, United States; Springfield, Illinois, United States; Morristown, New Jersey, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.