Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Behaviors and Mental Disorders

Carcinoma

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Pregnancy Complications

Genital Diseases, Female

Urogenital Diseases

Endocrine Gland Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Neoplasms, Glandular and Epithelial

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Genital Diseases

Adnexal Diseases

Ovarian Diseases

Gonadal Disorders

Urologic Diseases

Neoplasms by Histologic Type

Male Urogenital Diseases

Ovarian Cancer

Quality of Life

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Cisplatin

Ocoxin-Viusid® before, during and after the Chemotherapy treatment.

Ocoxin-Viusid group (Experimental): Oral solution Ocoxin-Viusid (30 ml vials) were used at a rate of 60ml / day (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatment will start a week before start Chemotheray treatment (CT) and, It will maintenance until 3 weeks after finished the last cycle of CT (3 cycles of CT of Carboplatin/Paclitaxel or Cisplatin/ Paclitaxel with neoadjuvant intent).

Ocoxin-Viusid

Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.

General Objectives -To identify the efficacy of the nutritional supplement Ocoxin-viusid to increase the quality of life of patients with epithelial advanced or metastatic ovarian cancer. Specific Objectives - Identify the influence of the research product on the nutritional status and quality of life of patients. - Describe the toxicity of the research product. - Identify the adverse reactions to the chemotherapy scheme and quantify the interruptions to it by acute toxicity.

Quality of life. It will be measured as: - EORTC Questionnaire QLQ-C30 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - EORTC Questionnaire QLQ-OV28 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at the beginning, in each cycle of QT and 3 weeks after the 3rd cycle of QT

Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer

Efficacy of the Oncoxin-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced or Metastatic Ovarian Epithelial Cancer. Clinical Trial Phase II.

It will measured by: - EORTC QLQ-C30 (Points of every item and final points)

Karnofsky index (Score of 0-100 points at intervals of 10)

EORTC QLQ-OV28 (Points of every item and final points)

Catalysis SL

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Carcinoma, Neuroendocrine

Colorectal Neoplasms

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Intestinal Diseases

Head and Neck Neoplasms

Colonic Diseases

Lung Neoplasms

Colonic Neoplasms

Lung Diseases

Gastrointestinal Diseases

Neuroendocrine Tumors

Gastrointestinal Neoplasms

Intestinal Neoplasms

Neoplasms, Germ Cell and Embryonal

Protein-Energy Malnutrition

Respiratory Tract Diseases

Thoracic Neoplasms

Digestive System Neoplasms

Respiratory Tract Neoplasms

Bronchial Neoplasms

Carcinoma, Bronchogenic

Neoplasms, Nerve Tissue

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Adenocarcinoma, Papillary

Rectal Diseases

Neoplasms, Neuroepithelial

Bronchial Diseases

Papillary Thyroid Carcinoma

Neuroendocrine Tumor

Thyroid Cancer, Medullary

Neuroepithelioma

Amino Acids

Pralsetinib

Tyrosine

Multiple doses of pralsetinib (BLU-667) for oral administration.

Oral dose of pralsetinib (BLU-667) as determined during Dose Escalation.

pralsetinib (BLU-667) is a potent and selective inhibitor of the RET mutations, fusions, and predicted resistant mutants

pralsetinib (BLU-667)

Clinical Trials

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.

The study consists of 2 parts, a dose-escalation part (Phase 1) and an expansion part (Phase 2). Both parts will enroll participants with advanced non-resectable NSCLC, advanced non-resectable thyroid cancer and other advanced solid tumors that have progressed following standard systemic therapy, have not adequately responded to standard systemic therapy, or the participants must be intolerant to or the Investigator has determined that treatment with standard therapy is not appropriate, or there must be no accepted standard therapy for their disease.

Phase 1 (Complete):

* Advanced MTC, NSCLC or other solid tumor
* 30-600mg (PO QD or BID)

Phase 2 (400mg QD):

* Group 1: RET fusion NSCLC previously treated with a platinum chemotherapy
* Group 2: RET fusion NSCLC not previously treated for metastatic disease
* Group 3: MTC previously treated with cabozantinib and/or vandetanib
* Group 4: MTC not previously treated with cabozantinib or vandetanib
* Group 5: Other solid tumors with a RET fusion not eligible for any of the other groups and previously treated with SOC or have no acceptable SOC for their tumor type as determined by the investigator
* Group 6: Any solid tumor with a RET alteration (fusion or mutation) previously treated with a selective RET Inhibitor
* Group 7: Other solid tumors with a RET mutation previously treated with SOC
* Group 8: RET fusion NSCLC previously treated with a platinum chemotherapy (China only)
* Group 9: MTC not previously treated with systemic therapy for advanced or metastatic disease (China only)

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or Response Assessment in Neuro-Oncology (RANO), as appropriate per tumor type

As assessed by RECIST v1.1 or RANO, as appropriate per tumor type

Clinical Benefit Rate (CBR), Duration of Response (DOR), Disease Control Rate (DCR), Progression Free Survival (PFS)

RET gene status (i.e. gene fusion partner or primary mutation and, for MTC, whether hereditary or sporadic)

Will be measured from lead II and will be corrected for heart rate (QTc)n using Fridericia's correction factors

Hoffmann-La Roche

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer	NCT03562897	Carcinoma Ovarian Neoplas... Endocrine Gland... Urogenital Neop... Ovarian Disease... Adnexal Disease... Genital Disease... Female Urogenit... Female Urogenit... Endocrine Syste... Gonadal Disorde... Genital Neoplas... Neoplasms, Glan...	Ocoxin-Viusid	18 Years -	Catalysis SL
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer	NCT03562897	Carcinoma Ovarian Neoplas... Endocrine Gland... Urogenital Neop... Ovarian Disease... Adnexal Disease... Genital Disease... Female Urogenit... Female Urogenit... Endocrine Syste... Gonadal Disorde... Genital Neoplas... Neoplasms, Glan...	Ocoxin-Viusid	18 Years -	Catalysis SL
Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors	NCT03037385	RET-altered Non... Medullary Thyro... RET-altered Pap... RET-altered Col... RET-altered Sol... Lung Neoplasm Carcinoma, Non-... Thyroid Disease... Thyroid Neoplas... Thyroid Cancer,... Carcinoma, Neur... Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra... Carcinoma, Bron... Bronchial Neopl... Endocrine Syste... Endocrine Gland... Head and Neck N... Adenocarcinoma,... Adenocarcinoma Carcinoma Neoplasms, Glan... Neoplasms by Hi... Neuroendocrine ... Neuroectodermal... Neoplasms, Germ... Neoplasms, Nerv... Colonic Neoplas... Colorectal Neop... Intestinal Neop... Gastrointestina... Digestive Syste... Digestive Syste... Gastrointestina... Colonic Disease... Intestinal Dise...	pralsetinib (BL...	18 Years -	Hoffmann-La Roche

Spots Global Cancer Trial Database for endocrine gland neoplasm