Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor

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: NCT04254939
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Blueprint Medicines Corporation
Information provided by (Responsible Party):
CStone Pharmaceuticals

Brief Summary:
This study is an open-label, multicenter, phase I/II study to evaluate the safety, PK and clinical efficacy of avapritinib in Chinese subjects with unresectable or metastatic GIST. The study consists of two parts: dose escalation (phase I) and dose expansion (phase II).

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: CS3007 (BLU-285) Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Study of Avapritinib in Chinese Subjects With Unresectable or Metastatic Gastrointestinal Stromal Tumor
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2022


Arm Intervention/treatment
Experimental: CS3007(BLU-285) Drug: CS3007 (BLU-285)
A modified "3+3" dose escalation design will be adopted. Each group will enroll 3-6 subjects. Avapritinib will be administered orally at the starting of 200 mg QD. A cycle consists of 28 consecutive days.




Primary Outcome Measures :
  1. Phase I: Recommended Phase II dose (RP2D), incidence of dose limiting toxicities (DLT) in Cycle 1, incidence and severity of adverse events and serious adverse events and changes in vital signs, clinical laboratory results and ECG findings [ Time Frame: at the end of Cycle 1 (each cycle is 28 days) for RP2D and DLT; during every cycle through 30 days after the last dose of study drug, an average of approximately 24 months, for other measures ]
  2. Phase II: ORR based on mRESIST 1.1 [ Time Frame: At Cycle 3 (each cycle is 28 days) Day 1, then every 2 cycles until Cycle 13, they every 3 cycles through study completion, disease progression or patient discontinuation from the study (whichever comes first), an average of approximately 24 months ]


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.


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

Inclusion criteria:

  1. For phase I study, the subject must have histologically or cytologically confirmed unresectable or metastatic GIST that progressed after imatinib and at least one additional TKI treatment, or who cannot tolerate the standard treatment or have D842V mutation in the PDGFRα gene.
  2. For phase II study:

    i) Group 1: Chinese subjects with unresectable GIST harboring D842V mutation in PDGFRα gene.

    ii) Group 2: Chinese subjects with unresectable GIST that has progressed following imatinib treatment or who don't tolerate imatinib (including in the adjuvant setting) and who have not received any other kinase inhibitor treatment. Patients must not have a known D842V mutation in PDGFRα gene.

    iii) Group 3: Chinese subjects with unresectable GIST that doesn't harbor D824V mutation in PDGFRα gene and that has progressed despite treatment with imatinib and at least another tyrosine kinase inhibitor.

  3. Subjects with at least one measurable lesion as defined per RECIST v1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to

Exclusion Criteria

  1. Subject has any of the laboratory results that meet exclusion criteria
  2. Subjects who have previously received antineoplastic medication, including Chinese herbal drugs or Chinese medicine products with antineoplastic indications, for less than 5 half-lives or 14 days, whichever is shorter, prior to the first dose of the investigational product.
  3. The subject received neutrophil growth factor support within 14 days prior to the first dose of investigational product.
  4. Subjects received treatment with a strong inhibitor or strong or moderate inducer of cytochrome P450 (CYP) 3A4 within 14 days prior to the first dose of study drug, or requires continuous intake of above medications or foods during study period.
  5. Subject received a major surgery (not including minor procedures, e.g., central venous catheterization, tumor needle biopsy, feeding tube placement) within 14 days prior to the first dose of investigational product.
  6. Diagnosis of any other malignancy within 1 year prior to the first dose of investigational product or the subject is under treatment for another malignancy.
  7. Corrected QT interval > 450 msec calculated using Fridericia's formula.
  8. Subject has history of seizure (e.g. epilepsy) or requires antiepileptic medication treatment.
  9. History of cerebrovascular accident or transient ischemic attack within one year prior to the first dose of the investigational product.
  10. Known risk of intracranial hemorrhage, e.g., history of cerebral aneurysm or subdural or subarachnoid hemorrhage.
  11. With primary brain malignancy or brain metastasis.
  12. With clinically significant, uncontrolled cardiovascular disease, including congestive heart failure of New York Heart Association (NYHA) class II, III or IV, myocardial infarction or unstable angina in the past 6 months, or uncontrolled hypertension.
  13. Unwilling or unable to comply with scheduled visits, treatment plan, laboratory tests or other study procedures/restrictions.
  14. With previous or current clinically significant disorder, medical condition, history of surgery, physical issue or laboratory finding, which, in the investigator's judgment, might affect the subject's safety, change the absorption, distribution, metabolism or excretion of the investigational product, or interfere with the evaluation of study result.

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): NCT04254939


Contacts
Layout table for location contacts
Contact: Wendie YUAN +86 21 61097678 cstonera@cstonepharma.com

Locations
Layout table for location information
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Contact: Lin SHEN, MD         
Sponsors and Collaborators
CStone Pharmaceuticals
Blueprint Medicines Corporation
Investigators
Layout table for investigator information
Principal Investigator: Lin SHEN, MD Beijing Cancer Hospital
Layout table for additonal information
Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04254939    
Other Study ID Numbers: CS3007-101
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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