Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Carcinoma

Breast Neoplasms

Glioma

Prostatic Neoplasms

Glioblastoma

Prostatic Neoplasms, Castration-Resistant

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Disease Attributes

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

NUV-422 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.

NUV-422 is an investigational drug for oral dosing.

NUV-422

At the time of study termination, NUV-422-02 was a first-in-human, open-label, Phase 1 dose escalation study designed to evaluate the safety and efficacy of NUV-422. The study population comprised adults with recurrent or refractory high-grade gliomas (HGGs), metastatic breast cancer (mBC), with and without brain metastases, and recurrent or refractory metastatic castration-resistant prostate cancer (mCRPC). All patients self-administered NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors

Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

Nuvation Bio Inc.

The purpose of this trail is to evaluate the performance of Genetron IDH1 PCR Kit in Glioma patients using real-time PCR method.

This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron IDH1 PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. Combined with the results of clinicopathological classification, the incidence of IDH1 gene R132H mutation in different subtypes was counted to evaluate the clinical performance of the Genetron IDH1 PCR Kit.

Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients

The main purpose of this study is: by evaluating the Genetron IDH1 PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.

Huashan Hospital

Zhejiang University

West China Hospital

The First Hospital of Jilin University

Genetron Health

Behaviors and Mental Disorders

Nervous System Diseases

Neurocognitive Disorders

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Mental Disorders

Psychotic Disorders

C-SMART intervention will be provided via telehealth. Participants will complete in-person neurocognitive testing (baseline, post-intervention) as well as surveys (baseline, post-session, post-intervention) via secure email link. Exit interviews will be conducted by Zoom.

The C-SMART intervention includes approximately 8 individual therapy sessions, each approximately 60 minutes in length, delivered weekly. C-SMART intervention components include cognitive rehabilitation and mindfulness training.

C-SMART

Sarah E Braun, PhD

Giuliana V Zarrella, BA

Sarah Braun, Ph.D

Giuliana Zarrella

The primary aims of this mixed-methods trial are to test the feasibility and acceptability of the novel Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) delivered via telehealth to patients with primary brain tumors and mild neurocognitive disorder (mNCD).

C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

Development of C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

There is no plan to share individual participant data (IPD) to other researchers at this time.

As evidenced by rates of participant screening, eligibility, and consent

As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention

As evidenced by the attendance rate at intervention sessions

As evidenced by the number of patients that complete post-intervention measures

After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Responses are ranked on a Likert-type scale from 1 being "Not at all" to 5 being "A great deal". Higher scores indicate greater satisfaction with the intervention session.

As evidenced by the number of patients that would recommend the intervention to others

The number of participants that complete exit interviews will be audio recorded and transcribed verbatim. The PI and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa\>.80)

Feasibility of research procedures will be assessed by the number of participants that complete the baseline survey, post-session survey, and the post-intervention survey.

American Psychological Foundation

Virginia Commonwealth University

All study participants follow the same dietary intervention; thus, no randomization will take place.

The study intervention consists of one fasting cycle of 72 hours prior to biopsy/resection. Depending on clinical condition, patients can be hospitalized during the course of the study (e.g. need for medical assistance due to immobilization). Patients in good clinical condition will be admitted on day 3.

Fasting

Michael W Ronellenfitsch, PD

Nutritional interventions such as ketogenic diet (KD) or fasting are currently under evaluation as anti-cancer treatment. In glioma patient cohorts, the feasibility and safety of fasting in addition to antitumor treatment has been shown. However, it is still unclear whether fasting exerts effects on the glioma tumor tissue at all, and whether fasting causes metabolic or immunological changes in the glioma microenvironment that could be exploited therapeutically. Therefore, the central contribution of this study is to characterize metabolic and immunological changes in the glioma tumor tissue induced by a fasting cycle of 72 hours prior to biopsy or resection.

Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)

The presence of ketone bodies in patient blood will be assessed by capillary sampling from a finger or an ear lobe. The presence of ketone bodies in urine will be assessed by urine test strips.

Main target parameters of MR spectroscopic imaging are detection of intracerebral ketone bodies (acetone, acetoacetate, beta-hydroxybutyrate), changes in lactate and adenosine triphosphate / adenosine diphosphate (ATP/ADP) concentrations and changes in intracellular pH (pHi) as determined from the chemical shift difference between inorganic phosphate (Pi) and phosphocreatine (PCr). Tumor tissue and healthy appearing normal white matter of the contralateral hemisphere will be examined.

Tumor tissue will be analysed by metabolome and proteome analysis and RNA sequencing.

Patient serum will be analysed by proteome analysis.

Flow cytometry including T- and B-lymphocytes natural killer (NK) cells in blood samples.

Analysis of gut microbiome prior to and following fasting.

Non-invasive electroencephalography (EEG) will be performed prior to and following fasting. It will be assessed with regard to chief frequencies and the presence of epilepsy-associated manifestations (e.g. epileptiform discharges, seizures).

Patients will be asked keep a dietary diary for days 0 to 4 reporting on their intake of fluids and/or calories.

A short questionnaire of 8 aspects concerning the tolerability of the diet will be handed out. The patients will be asked to grade their consensus to each statement by 1 to 5 where "1" is defined as "not at all" and 5 as "very relevant" for daily life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors	NCT04541225	Glioma Glioma, Maligna... Glioma, Mixed Glial Cell Tumo... Breast Cancer Breast Carcinom... Cancer of Breas... Cancer of the B... Breast Tumor Malignant Tumor... Advanced Breast... Advanced Breast... Metastatic Brea... Metastatic Brea... Prostate Cancer Prostatic Cance... Cancer of Prost... Cancer of the P... Prostate Neopla... Castrate Resist... Castration-resi... Castration Resi... Glioblastoma Recurrent Gliob...	NUV-422	18 Years -	Nuvation Bio Inc.
Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients	NCT05100173	Glioma, Maligna... Glioma, Mixed		-	Genetron Health
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors	NCT05984667	Glioma, Mixed Mild Neurocogni... Brain Tumor	C-SMART	18 Years -	Virginia Commonwealth University
Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)	NCT04461938	Glioma, Mixed	Fasting	18 Years -	Goethe University
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors	NCT05984667	Glioma, Mixed Mild Neurocogni... Brain Tumor	C-SMART	18 Years -	Virginia Commonwealth University
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors	NCT05984667	Glioma, Mixed Mild Neurocogni... Brain Tumor	C-SMART	18 Years -	Virginia Commonwealth University
Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors	NCT04541225	Glioma Glioma, Maligna... Glioma, Mixed Glial Cell Tumo... Breast Cancer Breast Carcinom... Cancer of Breas... Cancer of the B... Breast Tumor Malignant Tumor... Advanced Breast... Advanced Breast... Metastatic Brea... Metastatic Brea... Prostate Cancer Prostatic Cance... Cancer of Prost... Cancer of the P... Prostate Neopla... Castrate Resist... Castration-resi... Castration Resi... Glioblastoma Recurrent Gliob...	NUV-422	18 Years -	Nuvation Bio Inc.
Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)	NCT04461938	Glioma, Mixed	Fasting	18 Years -	Goethe University
Characterization of Metabolic Changes in the Glioma Tumor Tissue Induced by Transient Fasting (ERGO3)	NCT04461938	Glioma, Mixed	Fasting	18 Years -	Goethe University

Spots Global Cancer Trial Database for glioma, mixed