Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

All patients in first part will receive everolimus 10mg q.d.

All patients will receive everolimus 10mg q.d.

M.H.G. Langenberg, MD/PhD

N. Steeghs, MD/PhD

M.J.A. de Jonge, MD/PhD

The investigators hypothesize that certain mutations in the individual cancer genomes will predict response to Everolimus therapy. To identify possible genetic mutations that affect tumor response to Everolimus the investigators will obtain sequence analysis of tumors from all patients that will be treated with Everolimus in this study. Moreover, the investigators performed a systematic review of the currently available data to identify mutations that could be predictive for increased mTOR activity in cancer cells. These mutations have been described to lead to mTOR activation but their predictive value for response to Everolimus therapy remains unclear. The investigators will use the data generated in the investigators own prospective treatment study and the data from literature to select patients for entry into a second part of this trial. In this part the investigators want to test the hypothesis that selecting patients based on their specific genetic mutations increases the likelihood of response.

A Study to Identify a Biomarker Predictive for Response on Everolimus in Solid Tumors (CPCT-03)

A Two Parts, Biomarker Study to Identify Genetic Aberrations Predictive for Response on Everolimus in Solid Tumors Without Regular Treatment Options (CPCT-03)

Inclusion until earliest date of disease progression (defined as a 30% volumetric increase in tumorvolume or appearance of new lesions)

Time from initiation of everolimus to, either radiological (RECIST 1.1) or clinical disease progression or death from any cause.

Disease control rate (DCR) (DC = CR or PR or SD) as defined by RECIST 1.1 3 months after initiation of Everolimus.

Toxicity will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version v4.03: June 14, 2010

The (median) time from initiation of Everolimus to time of death or censored at the date of last follow-up. First analysis of overall survival will be performed within one year after inclusion of last subject.

UMC Utrecht

Investigator

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Stomach Neoplasms

Breast Neoplasms

Triple Negative Breast Neoplasms

Esophageal Neoplasms

Urinary Bladder Neoplasms

Carcinoma, Renal Cell

Small Cell Lung Carcinoma

Head and Neck Neoplasms

Kidney Neoplasms

Stomach Cancer

Esophageal Cancer

Renal Cell Carcinoma

Small Cell Lung Cancer

Herbal and Botanical

Cola

Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer

VIP236 will be administered by IV infusion once every 3 weeks.

VIP236

Vincerx Clinical Trials Contact

Research Site

Vincerx Study Director

Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer

All comers solid tumor subjects with histologically confirmed advanced or metastatic disease who have relapsed or refractory to standard of care. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.

Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer

An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity and Pharmacokinetics of VIP236 Monotherapy in Subjects With Advanced Cancer

Vincerx Pharma, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Identify a Biomarker Predictive for Response on Everolimus in Solid Tumors (CPCT-03)	NCT01566279	Unspecified Adu...	Everolimus	18 Years -	UMC Utrecht
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer	NCT05712889	Neoplasms	VIP236	18 Years -	Vincerx Pharma, Inc.
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer	NCT05712889	Neoplasms	VIP236	18 Years -	Vincerx Pharma, Inc.

Spots Global Cancer Trial Database for all comers

Every month we try and update this database with for all comers cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for all comers

Every month we try and update this database with for all comers cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for all comers cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.