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A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma and Other Non-small Cell Lung Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02897479
Recruitment Status : Unknown
Verified August 2021 by Hutchmed ( Hutchison Medipharma Limited ).
Recruitment status was:  Active, not recruiting
First Posted : September 13, 2016
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Hutchmed ( Hutchison Medipharma Limited )

Study Description
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Brief Summary:
This is a Phase II, open-label, multicenter study of Savolitinib administered orally once per day(QD) to locally advanced/metastatic PSC patients and other NSCLC patients with MET Exon 14 mutation. The targeted population is the patients with MET Exon 14 mutation who have failed prior systemic therapy (ies), or are unwilling or can not tolerate to receive chemotherapy. Pathological diagnosis will be confirmed retrospectively by the central pathological laboratory.

Condition or disease Intervention/treatment Phase
Lung Sarcomatoid Carcinoma Drug: Savolitinib Phase 2

Detailed Description:
Savolitinib will be administrated 600mg or 400mg once per day (QD). The treatment will be discontinued for the patients who experience disease progression, death or experience unacceptable toxicity, whichever occurs first. A cycle of study treatment will be defined as 21 days of continuous dosing.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label Study to Evaluate the Efficacy and Safety of HMPL-504 in Locally Advanced/Metastatic MET-Mutation-Positive Pulmonary Sarcomatoid Carcinomas and Other Non-small Cell Lung Cancer
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Savolitinib
Pulmonary Sarcomatoid Carcinomas
 Drug: Savolitinib
Enrolled patients will be treated with Savolitinib 600mg or 400mg once per day(QD), till disease progression, death or unacceptable toxicity, whichever comes first. A cycle of study treatment will be defined as 21 days of continuous dosing.
Other Name: hmpl-504


Outcome Measures
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Primary Outcome Measures :
  1. To assess objective response rate (ORR) [ Time Frame: 1year ]
    ORR is defined as the proportion of patients with complete response or partial response. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks and in this study, it could be performed by the scheduled tumor assessment 6 weeks later


Secondary Outcome Measures :
  1. Progression free survival(PFS) [ Time Frame: 1year ]
    PFS is defined as the Progression free surviva of patients with complete response or partial response or stable disease. In the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.

  2. Safety Assessment Parameter [ Time Frame: 1year ]
    The safety will be assessed using the following safety outcome measures: incidence of adverse events, physical examinations,vital signs and laboratory tests (including hematology, clinical chemistry, urine tests and other indicators)12-ECG parameters and echocardiogram.


Eligibility Criteria
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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.Fully understood the study and voluntarily signed Informed Consent Form
  • 2.Age > 18 years
  • 3.Histologically or cytologically documented locally advanced or Metastatic pulmonary sarcomatoid carcinoma (PSC) patients and other Non-small cell lung cancer（NSCLC） with MET Exon 14 mutation who have failed piror systemic therapy(ies), or are unwilling or unable to receive chemotherapy
  • 4.Patient should have measurable disease per RECIST1.1
  • 5.ECOG performance status of 0, or 1
  • 6.Expected survival > 12 weeks

Exclusion Criteria:

  • 1.Co-existing malignancy or malignancies diagnosed within the last 3 years other than lung cancer with the exception of adequately treated skin basal cell carcinoma or cervical cancer in situ.
  • 2.Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 3weeks prior to initiation of study treatment, or received TKI (for ex. EGFR-TKI) treatment within 2 week prior to initiation of study treatment
  • 3.Palliative radiation to bone metastases within 2 weeks prior to the initiation of study treatment
  • 4.Herbal therapy within 1 week prior to the initiation of study treatment
  • 5. has EGFR, ALK or ROS 1 positive mutation
Contacts and Locations
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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): NCT02897479


Locations
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China, Beijing
Beijing Cancer Hopspital
Beijing, Beijing, China
China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China, 210000
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: Shun LU, doctor Shanghai Chest Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02897479    
Other Study ID Numbers: 2016-504-00CH1
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms