Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Breast Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neoplasms, Unknown Primary

Carcinoma

Colorectal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urogenital Neoplasms

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Neoplasm Metastasis

Neoplastic Processes

Neuroendocrine Tumor

Neuroepithelioma

Advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas; as well as patients who are phase I trial candidates

Philippe Bedard, MD

Substantial progress has been made in the treatment of cancer through the use of targeted therapies, but what works for one patient might not work for another patient. Certain drugs are now being developed that target specific molecules in the body that are believed to be part of the disease.

Biomarkers are specific characteristics of the cancer that may help provide prognostic information (i.e. how well patients will be regardless of the treatments given) or help predict sensitivity or resistance to a specific treatment.

The study will collect archival tumor samples (previously collected biopsy or surgical tumor samples) to provide biomarker data about a patient's cancer, in order to help their physicians to identify which clinical trials of molecularly targeted therapies may be most appropriate for the patient in the future.

The increasing appreciation and identification of specific somatic mutations and other genetic aberrations that drive cancers leave us on the threshold of a new era of "personalized cancer medicine", in which specific biomarkers will be used to direct targeted agents only to those patients deemed most likely to respond. The potential medical, scientific and economic benefits of such a personalized approach to cancer therapy are immense and self-evident. Yet despite some important advances, only a limited number of approved targeted agents have had their approvals predicated on specific biomarkers of sensitivity or resistance.

The premises behind personalized cancer medicine include: i) genetic aberrations exist in human malignancies; ii) a subset of these aberrations, often present across multiple cancer types, have functional relevance as "hallmarks" or "drivers" for oncogenesis and tumor progression; iii) such genetic aberrations are potentially "druggable" targets; and iv) there are tolerable medicinal compounds that can effectively modulate such targets. A key requirement of this new, personalized approach to anti-cancer therapy is that specific patients must be matched to a particular drug or combination of drugs. Molecular profiling of tumors to identify somatic mutations and/or other genetic aberrations are examples of enrichment strategies to assist in matching patients to drugs or treatments that have gained increasing interest in the oncology community.

The present protocol seeks to provide molecular profiling data to the treating physician for patients with advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas, as well as patients who are phase I trial candidates, in order to help identify which standard regimens or clinical trials of molecularly targeted therapies may be most appropriate for the individual patient.

Archival tumor tissue

1 tube of whole blood

Integrated Molecular Profiling in Advanced Cancers Trial

Genotyping assays including: AKT1, HRAS, AKT2, JAK2, AKT3, KIT, BRAF, KRAS, CDK, MEK1, CTNNB1, MET, EGFR, NOTCH1, ERBB2, NRAS, FGFR1, PDGFRA, FGFR2, PIK3CA, FGFR3, RET, FGFR4, SMO, STK11

Including utilization of information for standard regimens or clinical trials of molecularly targeted therapies.

Princess Margaret Hospital, Canada

University Health Network, Toronto

Cholangiocarcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Bile Duct Cancer

Eligible patients that present with Cholangiocarcinoma.

Eligible patients with cancer of unknown primary site (CUP).

Eligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States).

Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.

FoundationOne CDx and FoundationOne Liquid CDx

Mary Oster

Shumei Kato, M.D

Razelle Kurzrock, M.D.

Vivek Subbiah, M.D.

Shumei Kato, M.D.

This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results.

This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results. The study leverages a remote consent and participation approach to open enrollment to all patients with rare tumors within the United States. Traditional, site-based patient consenting and participation is also available for enrollment to the study.

Each participant will undergo comprehensive genomic profiling (CGP) by Foundation Medicine Inc. (FMI) of their tumor as well as plasma circulating cell-free DNA. Plasma circulating cell-free DNA may be additionally collected for repeat CGP at various timepoints during the study.

The CGP findings will be provided by FMI directly to the treating physician and study sponsor TargetCancer Foundation (TCF), with TCF presenting cases with genomic findings to the Virtual Molecular Tumor Board (VMTB). The VMTB will analyze the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions. The resultant treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

The primary feasibility endpoint is the percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. Point estimates and confidence interval estimations will be calculated for percent of participants on matched treatments.

The primary efficacy endpoint is the progression-free survival (PFS) among participants who received the molecularly targeted matched treatment. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including progression-free survival (PFS). Cox regression analysis will be applied to model PFS by putative covariates such as performance status, type of tumor, prior lines of treatment, and whether matched treatments are received.

Tumor molecular profiles will be correlated to treatment outcome, assessed by measures including the response rate, the rate of stable disease (SD)\>6 months/partial response (PR)/complete response (CR), progression-free survival (PFS), PFS ratio (comparison of the PFS used after molecular profiling to PFS on prior treatment), time to treatment failure, and overall survival. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including overall survival (OS).

Foundation Medicine

TargetCancer Foundation

Richard F Schlenk, M.D.

Stefan Fröhling, M.D.

NCT/DKFZ/DKTK MASTER is a prospective, continuously recruiting, multicenter observational study for biology-guided stratification of adults with rare cancers, including rare subtypes of common entities, using comprehensive molecular profiling, and clinical decision-making in a multidisciplinary molecular tumor board.

Molecularly Aided Stratification for Tumor Eradication Research

NCT MASTER Plattform Molecularly Aided Stratification for Tumor Eradication Research

Time period of progression survival from date of multiomics analysis

time period of survival from date of diagnosis

response according to RECIST v.1.1 criteria to antitumor treatment applied after multiomics analysis

German Consortium for Translational Cancer Research

German Cancer Research Center

The study will include patients with rare gynecologic malignancies

this is an observational prospective study, therefore no intervention is planned. Patients perform medical and surgical treatment as per standard of case.

chemotherapy, surgery

Francesco Perrone, MD

Giorgia Mangili, MD

Sandr Pignata, MD

This is a prospective, observational, multicenter study on gynecological rare tumors.

This is a prospective registry aimed to better understand prognosis, clinical and pathological features, management of this rare cancer conditions for improving standard of care.

Study on Gynecological Rare Cancers

Prospective, Multicenter, Observational Study on Rare Gynecological Cancers

To describe the prevalence of gynecologic rare tumors

National Cancer Institute, Naples

Glioma

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Trametinib

Dabrafenib

Lactitol

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients in this study may receive:

- monotherapy of dabrafenib

Patients in this study may receive:

- monotherapy of trametinib

Patients in this study may receive:

- the combination of dabrafenib and trametinib

dabrafenib is available in capsules (50mg and 75mg) taken twice a day

dabrafenib

trametinib is available in tablets (0.5mg, 2mg dose)

trametinib

Novartis Pharmaceuticals

Angela Neuckranz

Michael Gordon

Michelle Capozzoli

Robert Kreitman

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

Dabrafenib and/or Trametinib Rollover Study

Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.

To evaluate clinical benefit as assessed by the Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Integrated Molecular Profiling in Advanced Cancers Trial	NCT01505400	Breast Cancer Non-small Cell ... Colorectal Canc... Genitourinary C... Pancreatobiliar... Upper Aerodiges... Gynecological C... Melanoma Cancer... Rare Cancers Unknown Primary...		18 Years -	University Health Network, Toronto
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
Molecularly Aided Stratification for Tumor Eradication Research	NCT05852522	Rare Cancers Multiomics		18 Years -	German Cancer Research Center
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
Molecularly Aided Stratification for Tumor Eradication Research	NCT05852522	Rare Cancers Multiomics		18 Years -	German Cancer Research Center
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
Study on Gynecological Rare Cancers	NCT05733806	Gynecologic Can...	chemotherapy, s...	-	National Cancer Institute, Naples
Dabrafenib and/or Trametinib Rollover Study	NCT03340506	Melanoma Non Small Cell ... Solid Tumor Rare Cancers High Grade Glio...	dabrafenib trametinib	18 Years - 100 Years	Novartis
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
Study on Gynecological Rare Cancers	NCT05733806	Gynecologic Can...	chemotherapy, s...	-	National Cancer Institute, Naples

Spots Global Cancer Trial Database for rare cancers

Every month we try and update this database with for rare cancers 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.