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A Study of HQP1351 in Patients With GIST or Other Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594422
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
HealthQuest Pharma Inc.
Information provided by (Responsible Party):
Ascentage Pharma Group Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor (GIST) Solid Tumor, Adult Drug: HQP1351 Phase 1

Detailed Description:
The primary objective of this phase 1 study is to determine the RP2D of HQP1351 in patients with GIST or other solid tumors. The secondary objective is to assess the safety, tolerability, PK and preliminary anti-tumor activities of HQP1351 in Patients With GIST or Other Solid Tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized at 1:1:1 ratio into the three dose cohorts: 30 mg QOD, 40 mg QOD and 50 mg QOD.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020


Arm Intervention/treatment
Experimental: HQP1351 30mg
30 mg QOD
Drug: HQP1351
HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.

Experimental: HQP1351 40mg
40 mg QOD
Drug: HQP1351
HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.

Experimental: HQP1351 50mg
50 mg QOD
Drug: HQP1351
HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.




Primary Outcome Measures :
  1. Safety and tolerance [ Time Frame: 30 days after the last dose of HQP1351 ]
    Patients with HQP1351 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03.


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1. [ Time Frame: 28 days ]
    Pharmacokinetic evaluation

  2. Area under the plasma concentration versus time curve (AUC) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1. [ Time Frame: 28 days ]
    Pharmacokinetic evaluation

  3. Anti-tumor activities of HQP1351 [ Time Frame: 3-6 months ]
    Response will be evaluated every 2 cycles (8 weeks), according to the revised RECIST Guideline, Version 1.1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or not pregnant or lactating women, age≥18 years.
  2. Advanced and/or metastatic GIST or other solid tumor subjects that are confirmed by histology and/or cytology. Among them, GIST patients are required primary imatinib resistance (PDGFRA D842V mutation or NF1 mutation) or failed to previous treatment with imatinib or imatinib and at least one other TKI.
  3. ECOG≤ 2.
  4. Estimated survival at least 3 months.
  5. Adequate hematologic and bone marrow functions.
  6. Adequate renal and liver function.
  7. Heart function index:

    • Troponin(I/T) ≤ Upper Limit of Normal;
    • Ejection fraction >40%;
    • QTc interval ≤ 450 ms in male or ≤ 470 ms in female.
  8. Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour prior to the first dose of investigational product.
  9. 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.
  10. 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).
  11. Willing and ability to comply with study procedures and follow-up examination.
  12. Willing to provide tumor samples (either archived tumor samples or fresh tumor biopsy ) for gene mutation detection.

Exclusion Criteria:

  1. 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.
  2. Received any TKIs within 14 days before first dose of HQP1351.
  3. Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.
  4. Have not recovered (> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.
  5. Malabsorption syndrome or other diseases that affect the absorption of oral drugs.
  6. 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 lower left ventricular ejection fraction (LVEF) than normal limit within 6 months; the history of atrial arrhythmias was judged by the researchers to have important clinical significance; history of ventricular arrhythmias, etc.
  7. Hypertension was still poorly controlled after medication treatment (SBP > 140 mmHg and/or DBP > 90 mmHg).
  8. Concurrent use any medication led to prolong QT interval.
  9. Pulmonary mean arterial pressure>35 mmHg by ECHO.
  10. Significant severe cardiovascular conditions during previous TKI treatment.
  11. Uncontrollable hypertriglyceridemia.
  12. Performed major surgery (except for intravenous catheterization or bone marrow biopsy) within 14 days of first dose of HQP1351.
  13. 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 deep vein thrombosis within 3 months before the first dose of HQP1351.
  14. Brain metastasis.
  15. 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 controlled prostate cancer).
  16. 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.
  17. Subjects who are known to be allergic to pharmaceutical ingredients or their analogs.
  18. Pregnancy or lactation, or expect to be pregnant during the study period.
  19. 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.
  20. Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594422


Contacts
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Contact: Yifan Zhai, M.D., Ph.D. +86-20-28069260 yzhai@ascentagepharma.com

Locations
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China, Guangdong
Sun-Yat Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ruihua Xu, Professor    +86-20-87343468    ruihxu@163.com   
Contact: Zhiwei Zhou, Professor         
Guangdong general hospital Recruiting
Guangzhou, Guangdong, China
Contact: Yong Li, Professor         
China, Hubei
Union Hospital medical college Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: Kaixiong Tao, Professor         
China
Chinese PLA general hospital, Beijing, China Recruiting
Beijing, China
Contact: Xin Wu, Professor         
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Ye Zhou, Professor         
Sponsors and Collaborators
Ascentage Pharma Group Inc.
HealthQuest Pharma Inc.
Investigators
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Principal Investigator: Ruihua Xu, Professor Sun Yat-sen University
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Responsible Party: Ascentage Pharma Group Inc.
ClinicalTrials.gov Identifier: NCT03594422    
Other Study ID Numbers: SJ-0003
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases