Advanced Refractory Solid Tumors With TP53 Mutations Register Study

NCT03927599 | Unknown

• 1 other identifier: PV-TP53
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Solid Tumor, Adult

Keywords

TP53; PARP; VEGFR; Solid tumor

Outcome Measures

Primary Outcomes (1)

• ORR(Objective Response Rate)

  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.

  Up to three months

Secondary Outcomes (3)

• PFS (Progression Free Survival), calculated from various time points

  Up to two years

• OS (Overall Survival), calculated from various time points

  Duration of time from the start of treatment to date of death, assessed up to two years

• ADR (Adverse Drug Reaction)

  30 days after last dose

Study Arms (1)

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

Interventions

Data Collection OTHER

Colleciton of data from medical records only

Advanced refractory tumor solid tumors patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Is equal to or greater than 18 years of age.
• 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).
• Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
• 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.
• Adequate baseline organ system function.
• Patients could receive treatment program from MTB (Molecular Tumor Board).
• No prior treatment with PARP combined with VEGFR inhibitions.
• Ability to understand and the willingness to provide a written informed consent document.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• 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.
• 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.
• Active infection requiring systemic therapy.
• Patients unable to swallow orally administered medication.
• Prior treatment with PARP or VEGFR inhibitions.
• 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.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, 300211, China

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Haitao Wang

  Tianjin Medical Unversity Second Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: August 20, 2019

Record last verified: 2019-04

Locations

CN (1)