Advanced Refractory Solid Tumors With TP53 Mutations Register Study

Solid Tumor, Adult Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03927599
• Other study ID #: PV-TP53
• Status: Enrolling by invitation
• Start date: August 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2019
• Source: Tianjin Medical University Second Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Other:
• Data Collection
Colleciton of data from medical records only

Locations

Country	Name	City	State
China	Tianjin Medical Unversity Second Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PFS (Progression Free Survival), calculated from various time points	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).	Up to two years
Secondary	OS (Overall Survival), calculated from various time points	OS is defined as time from initiation to death of any cause.	Duration of time from the start of treatment to date of death, assessed up to two years
Secondary	ADR (Adverse Drug Reaction)	Adverse events determined according to CTCAE (version 4.03).	30 days after last dose