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Efficacy and Safety of Targeted Precision Therapy in Refractory Tumor With Druggable Molecular Event

This study is currently recruiting participants.
Verified August 2017 by Baodong Qin, Shanghai Changzheng Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03239015
First Posted: August 3, 2017
Last Update Posted: August 3, 2017
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.
Information provided by (Responsible Party):
Baodong Qin, Shanghai Changzheng Hospital
  Purpose
This study is intended to evaluate efficacy and safety of targeted precision therapy in patients with refractory tumor, including rare tumor without standard recommended treatment and common tumor after multiple line of therapy.

Condition Intervention Phase
Rare Tumor Refractory Tumor Drug: Gefitinib Drug: Erlotinib Drug: Afatinib Drug: Trastuzumab Drug: Oxazolidine Drug: Olaparib Drug: Everolimus Drug: Cabozantinib Drug: Vemurafenib Drug: Dabrafenib Drug: Palbociclib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Targeted Precision Therapy in Refractory Tumor With Druggable Molecular Event

Further study details as provided by Baodong Qin, Shanghai Changzheng Hospital:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months ]
    Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission


Secondary Outcome Measures:
  • Progress Free Survival [ Time Frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months ]
    Time from treatment beginning until disease progression

  • Overall Survival [ Time Frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months ]
    Time from treatment beginning until death from any cause

  • Adverse Effect [ Time Frame: Through study completion, an average of 1 months ]
    Incidence of Treatment-related adverse Events


Estimated Enrollment: 60
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Targeted Drug Therapy Group
All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib.
Drug: Gefitinib
Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
Drug: Erlotinib
Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
Drug: Afatinib
Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
Drug: Trastuzumab
Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.
Drug: Oxazolidine
Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.
Drug: Olaparib
Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.
Drug: Everolimus
Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.
Drug: Cabozantinib
Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.
Drug: Vemurafenib
Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
Drug: Dabrafenib
Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
Drug: Palbociclib
Palbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results.

Detailed Description:
The individuals recruited in the present study are with solid tumor, mainly including two parts: first, rare tumor without standard recommended treatment such as atypical fibrous histiocytoma; second, common tumor after multiple line of therapy such as lung cancer, gastric cancer, colorectal cancer, etc. All patients have no any standard therapy based on NCCN guideline when recruiting. Next-generation sequence was used to detect druggable molecular event including gene mutation, gene fusion, amplification, etc. Then patients with molecular events were treated with corresponding targeted drug and followed-up, and not limited tumor type. The efficacy and safety of targeted drug were evaluated.
  Eligibility

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Malignant solid tumors diagnosed histologically;
  • Common solid tumor patients have no any standard choice after multiple line of therapy; Rare solid tumor did not have any standard recommended treatment;
  • Expected survival ≥ 1 month;
  • ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

  • Patient still has standard treatment therapy based on NCCN guidance;
  • Patient can not comply with research program requirements or follow-up;
  Contacts and Locations
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): NCT03239015


Contacts
Contact: Xiao-dong Jiao, MD.PHD +86-13817797639 pulava@163.com

Locations
China, Shanghai
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200003
Contact: Xiao-Dong Jiao, MD    +86-13817797639    pulava@139.com   
Sponsors and Collaborators
Baodong Qin
Investigators
Principal Investigator: Yuan-Sheng Zang, MD.PHD Shanghai Changzheng Hospital
  More Information

Responsible Party: Baodong Qin, Clinical Professor, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT03239015     History of Changes
Other Study ID Numbers: HETIAN64
First Submitted: July 28, 2017
First Posted: August 3, 2017
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Gefitinib
Olaparib
Palbociclib
Dabrafenib
Everolimus
Sirolimus
Trastuzumab
Erlotinib Hydrochloride
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors


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