Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04179656
Other study ID # BP-HER2
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date December 2019
Est. completion date December 2022

Study information

Verified date November 2019
Source Tianjin Medical University Second Hospital
Contact Haitao Wang
Phone (022)28331788
Email peterrock2000@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open-label, Phase 2 study exploring the efficacy and safety of 马来酸Pyrotinib Maleate Tablets in patients with solid tumors with activating(harmful) HER2 mutations or with HER2 gene amplification or immunohistochemical staining (IHC) assay showing HER2 is 3+ and / or fluorescence in situ hybridization (FISH) positive.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria

1. Patients between the ages of 18 and 75;

2. ECOG physical status score 0-2 points;

3. The estimated total survival period is not less than 12 weeks;

4. Patients with HER2-positive solid tumors confirmed by pathology and identified as advanced tumors by clinicians or centers;

5. HER2 positive: refers to standard immunohistochemical staining (IHC) assay showing HER2 is 3+ and / or fluorescence in situ hybridization (FISH) positive or after second generation sequencing shows HER2 amplification and copy number = 3, or There is a HER2 activating mutation identified by the Molecular Oncology Committee (confirmed by the investigator at the test center) ;

6. Imaging studies have at least one measurable lesion with a diameter = 10 mm;

7. Pilotinib has not been used for the past 3 months;

8. The main organs function normally, they meet the following criteria:

1. Blood routine examination criteria are to comply with:

?.Hb=100 g/L; ?.ANC = 1.5 × 109 / L; ?.PLT=75×109 /L;

2. Biochemical tests are subject to the following criteria

?.TBIL = 1.5 × ULN (upper limit of normal value);

?.ALT and AST = 2.5 × ULN; if there is liver metastasis, ALT and AST = 5 × ULN;

?.Serum creatinine = 1.5 × ULN, creatinine clearance = 50ml / min (based on Cockroft and Gault formula);

3. Heart color ultrasound: Left ventricular ejection fraction (LVEF) = 50%;

9. The patient or his legal guardian understands the test procedure and content and signs an informed consent form (ICF) to provide true and effective information in accordance with the research and follow-up procedures;

Exclusion Criteria:

1. There is a third interstitial fluid that cannot be controlled by drainage or other methods, such as pleural effusion and ascites;

2. It has many factors affecting the oral and absorption of drugs (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction);

3. Those who have been confirmed to be allergic to the drug components of this program;

4. Patients who are known to be pregnant or planning to become pregnant, or gestational age patients who are unwilling to take effective contraceptive measures throughout the trial;

5. Patients with severe concomitant diseases or those considered by the investigator to be unsuitable for inclusion.

6. The investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study (for administrative reasons or for other reasons).

Study Design


Intervention

Drug:
Pyrotinib
400 mg administered orally, once daily, continuously in 21 day cycles

Locations

Country Name City State
China Tianjin Medical University Second Hospital Tianjin Tianjin

Sponsors (2)

Lead Sponsor Collaborator
Tianjin Medical University Second Hospital Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate Objective response rate defined as the patients confirmed complete response or partial response under RECIST 1.0 criteria. at least 3 months
Secondary Progression free survival Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression up to 24 months
Secondary Duration of Response The first evaluation of treatment efficacy is the time fromcomplete response or partial response to the first assessment of disease progression or death from any cause. up to 24 months
Secondary Disease Control Rate Objective response rate defined as the patients confirmed complete response or partial response or stable disease under RECIST 1.0 criteria. up to 24 months
Secondary Overall Survival Overall survival estimated using Kaplan-Meier methods is defined as the time from treatment initiation to death by any cause up to 36 months
Secondary Safety (Adverse Events and Serious Adverse Events) From consent through 28 days following treatment completion (estimated 6 months) up to 36 months
See also
  Status Clinical Trial Phase
Recruiting NCT05580991 - Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors Phase 1
Recruiting NCT05691608 - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 N/A
Active, not recruiting NCT02846038 - Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
Recruiting NCT05159388 - A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT03181854 - Randomized Controlled Trial of Integrated Early Palliative Care N/A
Recruiting NCT06014502 - Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors Phase 1
Recruiting NCT05981703 - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT04107311 - Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
Active, not recruiting NCT04078152 - Durvalumab Long-Term Safety and Efficacy Study Phase 4
Completed NCT02250157 - A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies Phase 1
Recruiting NCT05566574 - A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT03943004 - Trial of DFP-14927 in Advanced Solid Tumors Phase 1
Recruiting NCT06036836 - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) Phase 2
Recruiting NCT05525858 - KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Recruiting NCT05798546 - Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02) Phase 1
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT00479128 - Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors Phase 1
Recruiting NCT04143789 - Evaluation of AP-002 in Patients With Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2