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New treatment option for Gastrointestinal Stromal Tumor (GIST)
Official title A Study of HQP1351 in Patients With GIST or Other Solid Tumors
ClinicalTrials.gov ID: NCT03594422
What this study is testing
What is HQP1351?
HQP1351 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gastrointestinal stromal tumor (gist).
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
- This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male or not pregnant or lactating women, age≥12years.
- Advanced and/or metastatic GIST or other solid tumors, confirmed by histology and/or cytology. GIST patients must be primary resistant to imatinib...
- ECOG≤ 2.
- Estimated survival at least 3 months.
- Adequate hematologic and bone marrow functions.
You likely can't join if
- Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days...
- Received any TKIs within 14 days before first dose of HQP1351.
- Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.
- Have not recovered (\> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.
- Malabsorption syndrome or other diseases that affect the absorption of oral drugs.
- Cardiovascular diseases of clinical significance, uncontrollable or active, including but not limited to: history of myocardial infarction; unstable...
See the full eligibility criteria
- Male or not pregnant or lactating women, age≥12years.
- Advanced and/or metastatic GIST or other solid tumors, confirmed by histology and/or cytology. GIST patients must be primary resistant to imatinib (tumor progresses within 6 months first-line imatinib treatment, or...
- ECOG≤ 2.
- Estimated survival at least 3 months.
- Adequate hematologic and bone marrow functions.
- Adequate renal and liver function.
- Heart function index:
- Troponin(I/T) ≤ Upper Limit of Normal;
- Ejection fraction \>40%;
- QTc interval ≤ 450 ms in male or ≤ 470 ms in female.
- Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour prior to the first dose of investigational product.
- Willing to use contraception by a method that is deemed effective by the investigator by Subject and their partners throughout the treatment period and for at least 30 days following the last dose of study drug.
- Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures).
- Willing and ability to comply with study procedures and follow-up examination.
- Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days or 5 times half- time before first dose of HQP1351.
- Received any TKIs within 14 days before first dose of HQP1351.
- Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.
- Have not recovered (\> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.
- Malabsorption syndrome or other diseases that affect the absorption of oral drugs.
- Cardiovascular diseases of clinical significance, uncontrollable or active, including but not limited to: history of myocardial infarction; unstable history of angina pectoris; a history of congestive heart failure or...
- Hypertension was still poorly controlled after medication treatment (SBP \> 140 mmHg and/or DBP \> 90 mmHg).
- Concurrent use any medication led to prolong QT interval.
- Pulmonary mean arterial pressure\>35 mmHg by ECHO.
- Significant severe cardiovascular conditions during previous TKI treatment.
- Uncontrollable hypertriglyceridemia.
- Performed major surgery (except for intravenous catheterization or bone marrow biopsy) within 14 days of first dose of HQP1351.
- Arterial thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, TIA), or venous thrombosis events or pulmonary embolism within 6 months before the first dose of HQP1351 or...
- Brain metastasis.
- Had other primary malignant tumors in the last three years (exception of the tumors being cured for 5 years or more, or complete removal of non-melanoma skin cancer or successful treatment of carcinoma in situ, or the...
- Had active, symptomatic infections (including known infections of HIV, viral hepatitis (A, B, or C)). If there is no history of infection, screening is not required.
- people who are known to be allergic to pharmaceutical ingredients or their analogs.
- Pregnancy or lactation, or expect to be pregnant during the study period.
- According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may jeopardize the safety or safety assessment of the subject.
- Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Beijing, China
- Shanghai, China
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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Beijing, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.