Clinical Trials/NCT03594422

NCT03594422

Recruiting

Phase 1

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.

Ascentage Pharma Group Inc.6 sites in 1 country100 target enrollmentJuly 11, 2018

ConditionsGastrointestinal Stromal Tumor (GIST)Solid Tumor, Adult

InterventionsHQP1351

DrugsHQP1351

Overview

Phase: Phase 1
Intervention: HQP1351
Conditions: Gastrointestinal Stromal Tumor (GIST)
Sponsor: Ascentage Pharma Group Inc.
Enrollment: 100
Locations: 6
Primary Endpoint: Safety and tolerance
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

July 11, 2018

End Date

December 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ascentage Pharma Group Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion 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 succinate dehydrogenase B (SDHB) deficient confirmed by immunohistochemistry, or NF1 mutation), OR imatinib or imatinib and at least one other TKI treatment failure (after imatinib or other TKI treatment for more than 6 months, tumor progress again after achieving tumor remission or stability).
•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.

Exclusion Criteria

•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 HQP
•Received any TKIs within 14 days before first dose of HQP
•Attended any clinical trials on other drugs within 14 days before first dose of HQP
•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 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.
•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.

Arms & Interventions

HQP1351 30mg

30 mg QOD(Minor subjects will be enrolled based on weight)

Intervention: HQP1351

HQP1351 40mg

40 mg QOD(Minor subjects will be enrolled based on weight)

Intervention: HQP1351

HQP1351 50mg

50 mg QOD

Intervention: HQP1351

HQP1351 20mg

20 mg QOD (Minor subjects will be enrolled based on weight)

Intervention: HQP1351

Outcomes

Primary Outcomes

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 Outcomes

Maximum plasma concentration (Cmax) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.(28 days)
Area under the plasma concentration versus time curve (AUC) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.(28 days)
Anti-tumor activities of HQP1351(3-60 months)