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出境医 / 临床实验 / Advanced Refractory Solid Tumors With TP53 Mutations Register Study

Advanced Refractory Solid Tumors With TP53 Mutations Register Study

Study Description
Brief Summary:
The efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor will be investigated in advanced refractory solid tumors patients with TP53 mutation .

Condition or disease Intervention/treatment
Solid Tumor, Adult Other: Data Collection

Detailed Description:
TP53 is a well-known tumor suppressor gene. Multiple studies have demonstrated that TP53 mutations are poor prognostic factor in advanced solid tumor, the TP53 gene is frequently inactivated by mutation in a majority of human tumors. However, no effective TP53 -based therapy has been successfully translated into clinical cancer treatment. So, investigators intend to review and evaluate the efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor for TP53 mutation in advanced refractory solid tumors patients from a real-world population.
Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Other
Official Title: Prospective and Retrospective Register Study of PARP-Inhibitors Combined With VEGFR-Inhibitors for Treatment of Advanced Refractory Solid Tumors Patients With TP53 Mutations
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Advanced refractory tumor solid tumors patients
Patients with advanced refractory solid tumors carrying TP53 mutations and receive PARP-inhibitors in combination with the VEGFR-inhibitors therapy
 Other: Data Collection
Colleciton of data from medical records only
Outcome Measures
Primary Outcome Measures :
  1. ORR(Objective Response Rate) [ Time Frame: Up to three months ]
    ORR is the percentage of participants with best overall response of complete response (CR), partial response (PR). Response categories: CR, PR, SD (stable disease), PD (progressive disease) Criteria on which physicians determined therapy response also will be captured by using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 to evaluate.


Secondary Outcome Measures :
  1. PFS (Progression Free Survival), calculated from various time points [ Time Frame: Up to two years ]
    Progression-free survival (PFS) is defined as progression free survival of all the evaluable participants who receive targeted drug therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).

  2. OS (Overall Survival), calculated from various time points [ Time Frame: Duration of time from the start of treatment to date of death, assessed up to two years ]
    OS is defined as time from initiation to death of any cause.

  3. ADR (Adverse Drug Reaction) [ Time Frame: 30 days after last dose ]
    Adverse events determined according to CTCAE (version 4.03).


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
Sampling Method:   Non-Probability Sample
Study Population
The objective is to describe in a real-world population.First of all, this study will be carried out as a retrospective, observational review of patients who clinically diagnosed as advanced refractory solid tumors received PARP-inhibitors combined with VEGFR-inhibitors drug therapy, from January 01, 2016 to August 01, 2018. The TP53 gene status must confirm by NGS (Next Generation Sequencing). Then, the investigators prospective observation effectiveness and safety of PARP-inhibitors combined with VEGFR-inhibitors therapy for patients who clinically diagnosed as advanced refractory solid tumors according to the inclusion and exclusion criteria. Those patients should have a NGS report to show the TP53 gene status.
Criteria

Inclusion Criteria:

  1. Is equal to or greater than 18 years of age.
  2. Histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (Eastern Cooperative Oncology Group (ECOG) 3 and 4).
  3. Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  4. Patients must be able to provide blood samples or tissue samples for NGS (Next Generation Sequencing) testing for understanding the TP53 gene status. The amount of blood and tissue samples should be able to meet the requirements of DNA extraction and quality control.
  5. Adequate baseline organ system function.
  6. Patients could receive treatment program from MTB (Molecular Tumor Board).
  7. No prior treatment with PARP combined with VEGFR inhibitions.
  8. Ability to understand and the willingness to provide a written informed consent document.

Exclusion Criteria:

  1. Women who are pregnant or breastfeeding.
  2. Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.
  3. Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
  4. Active infection requiring systemic therapy.
  5. Patients unable to swallow orally administered medication.
  6. Prior treatment with PARP or VEGFR inhibitions.
  7. According to the investigator'judgment, there are serious, uncontrollable risks to patients'safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.
Contacts and Locations

Locations
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China, Tianjin
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin, China, 300211
Sponsors and Collaborators
Tianjin Medical University Second Hospital
Investigators
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Principal Investigator: Haitao Wang Tianjin Medical Unversity Second Hospital
Tracking Information
First Submitted Date April 22, 2019
First Posted Date April 25, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date August 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019) 		ORR(Objective Response Rate) [ Time Frame: Up to three months ]
ORR is the percentage of participants with best overall response of complete response (CR), partial response (PR). Response categories: CR, PR, SD (stable disease), PD (progressive disease) Criteria on which physicians determined therapy response also will be captured by using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 to evaluate.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 24, 2019)
  • PFS (Progression Free Survival), calculated from various time points [ Time Frame: Up to two years ]
    Progression-free survival (PFS) is defined as progression free survival of all the evaluable participants who receive targeted drug therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).
  • OS (Overall Survival), calculated from various time points [ Time Frame: Duration of time from the start of treatment to date of death, assessed up to two years ]
    OS is defined as time from initiation to death of any cause.
  • ADR (Adverse Drug Reaction) [ Time Frame: 30 days after last dose ]
    Adverse events determined according to CTCAE (version 4.03).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Advanced Refractory Solid Tumors With TP53 Mutations Register Study
Official Title Prospective and Retrospective Register Study of PARP-Inhibitors Combined With VEGFR-Inhibitors for Treatment of Advanced Refractory Solid Tumors Patients With TP53 Mutations
Brief Summary The efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor will be investigated in advanced refractory solid tumors patients with TP53 mutation .
Detailed Description TP53 is a well-known tumor suppressor gene. Multiple studies have demonstrated that TP53 mutations are poor prognostic factor in advanced solid tumor, the TP53 gene is frequently inactivated by mutation in a majority of human tumors. However, no effective TP53 -based therapy has been successfully translated into clinical cancer treatment. So, investigators intend to review and evaluate the efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor for TP53 mutation in advanced refractory solid tumors patients from a real-world population.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The objective is to describe in a real-world population.First of all, this study will be carried out as a retrospective, observational review of patients who clinically diagnosed as advanced refractory solid tumors received PARP-inhibitors combined with VEGFR-inhibitors drug therapy, from January 01, 2016 to August 01, 2018. The TP53 gene status must confirm by NGS (Next Generation Sequencing). Then, the investigators prospective observation effectiveness and safety of PARP-inhibitors combined with VEGFR-inhibitors therapy for patients who clinically diagnosed as advanced refractory solid tumors according to the inclusion and exclusion criteria. Those patients should have a NGS report to show the TP53 gene status.
Condition Solid Tumor, Adult
Intervention Other: Data Collection
Colleciton of data from medical records only
Study Groups/Cohorts Advanced refractory tumor solid tumors patients
Patients with advanced refractory solid tumors carrying TP53 mutations and receive PARP-inhibitors in combination with the VEGFR-inhibitors therapy
Intervention: Other: Data Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: April 24, 2019) 		100
Original Actual Enrollment Same as current
Estimated Study Completion Date January 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Is equal to or greater than 18 years of age.
  2. Histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (Eastern Cooperative Oncology Group (ECOG) 3 and 4).
  3. Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  4. Patients must be able to provide blood samples or tissue samples for NGS (Next Generation Sequencing) testing for understanding the TP53 gene status. The amount of blood and tissue samples should be able to meet the requirements of DNA extraction and quality control.
  5. Adequate baseline organ system function.
  6. Patients could receive treatment program from MTB (Molecular Tumor Board).
  7. No prior treatment with PARP combined with VEGFR inhibitions.
  8. Ability to understand and the willingness to provide a written informed consent document.

Exclusion Criteria:

  1. Women who are pregnant or breastfeeding.
  2. Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.
  3. Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
  4. Active infection requiring systemic therapy.
  5. Patients unable to swallow orally administered medication.
  6. Prior treatment with PARP or VEGFR inhibitions.
  7. According to the investigator'judgment, there are serious, uncontrollable risks to patients'safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03927599
Other Study ID Numbers PV-TP53
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Tianjin Medical University Second Hospital
Study Sponsor Tianjin Medical University Second Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Haitao Wang Tianjin Medical Unversity Second Hospital
PRS Account Tianjin Medical University Second Hospital
Verification Date April 2019

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