Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Prostatic Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Patients will receive XL309 once daily in sequential cohorts of increasing doses.

Patients will receive XL309 once daily in sequential cohorts of increasing dose in combination with olaparib.

The recommended dose as determined in the Escalation Stage will be further studied in advanced solid tumor-specific cohorts.

The recommended dose as determined in the Escalation Stage will be further studied in combination with olaparib in advanced solid tumor-specific cohorts.

XL309 will be administered orally once daily.

XL309 (ISM3091)

Olaparib administered orally twice daily.

Exelixis Clinical Trials

This is a FIH, multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as PK and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in subjects with advanced solid tumors.

A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Patients With Advanced Solid Tumors

An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients With Advanced Solid Tumors

To assess the safety and tolerability and to establish a preliminary RD of XL309 as monotherapy and in combination. Incidence of dose-limiting toxicities (DLTs).

Incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs). AEs and SAEs that lead to any dose modification, AEs and SAEs leading to discontinuation or deaths.

PK parameters, including AUC, Cmax, Tmax, clearance, Cmin.

To further assess the safety and tolerability of XL309 as monotherapy and in combination.

To assess preliminary efficacy of XL309 as monotherapy and in combination.

Incidence of treatment-emergent AEs, SAEs, AEs and SAEs leading to dose reduction, delay, discontinuation or deaths.

ORR per PCWG3 criteria for prostate cancer and RECIST version 1.1 for all other solid tumors as assessed by Investigator.

To characterize the PK of XL309 alone and when given in combination following a single dose administration and at a steady state after multiple dosing.

Concentration of XL309 agent and olaparib in plasma at specified time points

Concentration of XL309 and olaparib in plasma at specified time points.

Exelixis

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Genetic Predisposition to Disease

Disease Susceptibility

Hereditary Breast and Ovarian Cancer Syndrome

Carcinoma

Syndrome

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Breast Diseases

Skin Diseases

standardized data collection and 10-year prospective follow-up

Questionnaires

Dominique GENRE, MD

Margot BERLINE, MSc, MBA

Catherine NOGUES, MD

Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation

risk that a subject with a mutation develops breast and / or ovarian cancer during his lifetime, assessed by epidemiologic questionnaires (carcinologic events).

UNICANCER - Le Groupe génétique et cancer (GGC)

Institut Paoli-Calmettes

Behaviors and Mental Disorders

Quality of Life

Meditation and Breast Cancer: Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.

Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.

Mindfulness based meditation program

Mary E Charlson, MD

Joseph Loizzo, MD,PhD

Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.

The objective of this project in women recently treated for breast or other gynecologic cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. Quality of life will be assessed at 12 months.

The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers

The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers:Avon Program for Meditation and Healing

Avon Foundation

Weill Medical College of Cornell University

Principal Investigator

Tumor RNA Disruption Assay™ (RDA) to generate RDA score from fine needle aspiration biopsy samples of breast cancer obtained 7-14 days after the first, second and third cycles of neoadjuvant chemotherapy; and, if there is a change of chemotherapy regimen, after the first cycle of the new chemotherapy.

Tumor RNA Disruption Assay™ (RDA)

Murray Krahn, MD,MSc,FRCPC

The purpose of this study is to find out if the pathological complete response (pCR) to chemotherapy given before surgery (neoadjuvant chemotherapy) could be predicted by the evaluation of the RNA (ribonucleic acids) disruption pattern (RNA Disruption Assay or RDA score) obtained from a biopsy of the tumor 7 - 14 days after the first, second and third cycles of chemotherapy treatment. If we can determine the optimal time during neoadjuvant chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast cancer management.

When administering neoadjuvant chemotherapy, the current practice of monitoring response to treatment is by measuring the size of the breast tumor after each cycle of chemotherapy. The drawback to this method is, it will take several weeks before we can actually measure a significant change in size; and the initial response to chemotherapy is often evident as a softening of the tumor without an apparent decrease of the tumor size. Finding a reliable way to identify early response to chemotherapy would be helpful to enable matching of chemotherapy to an individual's need.

In a previous trial of breast cancer treated with neoadjuvant chemotherapy, researchers have identified that the pCR to a full treatment of chemotherapy could be predicted by the change in RNA pattern obtained from a biopsy of the tumor half way through the chemotherapy course. \[Parissenti et al. 2010\] The purpose of this study is to determine if we can predict the pCR to neoadjuvant chemotherapy by examining the pattern of RNA disruption (RNA Disruption Assay or RDA score) from breast biopsy tissue obtained 7 to 14 days after the first, second and third cycle of chemotherapy. If we can determine the optimal time during neoadjuvant chemotherapy to measure the RDA score for the prediction of pCR, we can optimize breast cancer management. For example, if RDA score can identify non-responders earlier, we can switch to other chemotherapy agents and reduce the exposure to the unnecessary side-effects of ineffective treatment.

Study of Tumor RNA Disruption Assay™ (RDA)

Study of Tumor RNA Disruption Assay™ (RDA) and Its Association With a Response to Neoadjuvant Chemotherapy in Breast Cancer - A Prospective Mixed-Methods Study

The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and the pCR to neoadjuvant chemotherapy will be evaluated. pCR is defined as no evidence of invasive carcinoma in the breast and lymph nodes (ypT0/Tis ypN0/N0itc) on histology at the time of surgery (lumpectomy or mastectomy).

The capacity of RDA score to predict pCR to neoadjuvant chemotherapy will be assessed by exploring for a cut point on the RDA score to differentiate subjects with a high likelihood of achieving pCR versus those who are less likely to achieve pCR.

The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and clinical response to neoadjuvant chemotherapy treatment will be evaluated.

We shall seek to understand the experiences of patients with the FNAB procedure and with the cancer care they received while participating in the study by conducting qualitative interviews of study subjects.

The cost-effectiveness of using RDA score to guide neoadjuvant chemotherapy will be evaluated by measuring the cost-effectiveness of monitoring pCR to neoadjuvant chemotherapy through the RDA score and in modifying the neoadjuvant chemotherapy regimen for non-pCR patients accordingly.

The association between tumor RDA score measured 7-14 days after the first, second and third cycles of chemotherapy and DFS will be evaluated. DFS will be measured as the time from patient's enrollment to the event of cancer metastasis or recurrence, or death, whatever comes first.

University Health Network, Toronto

University of Toronto

MD, MSc, FRCPC

Respiratory Tract (Lung and Bronchial) Diseases

Colorectal Neoplasms

Carcinoma, Renal Cell

Glioblastoma

Sarcoma

Mesothelioma

Mesothelioma, Malignant

Wilms Tumor

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenoma

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Soft Tissue Sarcoma

Malignant Mesothelioma

Wilms' Tumor

Neuroepithelioma

4 biweekly intradermal DC injections of 10\*10E6 DCs (500 µL) at 5 sites (100 µL/site) in the ventromedial regions of the upper arm approximately 5-10 cm of the regional lymph nodes

autologous dendritic cell vaccination

The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal vaccination with autologous RNA-modified dendritic cells (DCs) - engineered to express the WT1 protein - in patients with limited spread metastatic solid tumors, i.e. breast cancers, glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the results of our previously performed phase I study with autologous WT1 mRNA-transfected DC, the investigators hypothesize that the vaccination with DC will be well-tolerated and will result in an increase in WT1-specific CD8+ T cell responses.

Dendritic Cell Vaccination for Patients With Solid Tumors

Therapeutic Efficacy of Wilms' Tumor Gene (WT1) mRNA-electroporated Autologous Dendritic Cell Vaccination in Patients With Solid Tumors: a Phase I/Feasibility Study

Immunogenicity of intradermal DC vaccination (cellular + humoral immunity against WT1 antigen) as measured by:

1. In vivo cytokine response (serum concentration of cytokines)
2. In vivo anti-WT1 antibody responses
3. In vitro T cell reactivity towards MHC class I and II-restricted WT1 epitopes by multiplex-cytokine assay using peripheral blood and DTH-infiltrating T cells
4. Delayed type hypersensitivity (DTH) responses
5. Quantitative and qualitative FACS analysis of WT1-specific-positive CD8+ T cells using HLA-A2 WT1 multimers

University Hospital, Antwerp

120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan

10 female volunteers with normal breast who will be studied to refine imaging techniques and for comparison with patients. To the degree possible, the volunteer group will be age-matched to patients with symptoms, initially 30 to 70 years of age.

Ultrasound Scan

To determine how well from ultrasound scans, changes in malignant masses can be measured, and to whether the use of a dye visible by ultrasound will be useful in evaluating different therapies for breast cancer.

Mammography and Ultrasound

Paul L. Carson, Ph.D.

Paul Carson, PhD

The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.

To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.

Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies

3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies

Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Patients With Advanced Solid Tumors	NCT05932862	Advanced Solid ...	XL309 (ISM3091) Olaparib	18 Years -	Exelixis
Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation	NCT03667417	Breast Cancers Ovarian Cancers	Questionnaires	18 Years -	Institut Paoli-Calmettes
The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers	NCT00248911	Breast Cancers Gynecologic Can...	Mindfulness bas...	18 Years - 101 Years	Weill Medical College of Cornell University
Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation	NCT03667417	Breast Cancers Ovarian Cancers	Questionnaires	18 Years -	Institut Paoli-Calmettes
Study of Tumor RNA Disruption Assay™ (RDA)	NCT02239315	Breast Neoplasm...	Tumor RNA Disru...	18 Years -	University of Toronto
Dendritic Cell Vaccination for Patients With Solid Tumors	NCT01291420	Glioblastoma Renal Cell Carc... Sarcomas Breast Cancers Malignant Mesot... Colorectal Tumo...	autologous dend...	18 Years -	University Hospital, Antwerp
The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers	NCT00248911	Breast Cancers Gynecologic Can...	Mindfulness bas...	18 Years - 101 Years	Weill Medical College of Cornell University
Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies	NCT00721903	Breast Cancers	Ultrasound Scan Mammography and...	25 Years -	University of Michigan

Spots Global Cancer Trial Database for breast cancers