Loading clinical trials...

BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study | Clinical Trials | Clareo Health

TERMINATEDPHASE1

BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study

BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Phase I Study

NCT02550743•howard safran

View on ClinicalTrials.gov

Summary

The primary goal of this Brown University Oncology Research Group is to determine that a safe dose of BYL719 can be administered with capecitabine and radiation in patients with rectal cancer. Therefore, the threshold of success for this phase I study is to establish safety.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically proven adenocarcinoma of the rectum with no evidence of distant metastases.
•The tumor must be clinically Stage II (T3-4 N0) or stage III (N+). Stage of the tumor may be determined by CT scan, endorectal ultrasound or MRI. (For patients receiving chemotherapy prior to protocol chemoradiation, the initial clinical stage applies. CT/MRI/PET should be performed within 2 months of study entry to exclude disease progression.). For the MTD expansion phase only: patients who are stage IV, and in whom it is planned to administer capecitabine and radiation then have a resection of their rectal cancer, are also eligible.
•Measurable disease not required at baseline. Patient's without measurable disease may be enrolled as long as they clinically meet stage II or III criteria or for MTD expansion phase: also stage IV.
•Patients must not have received pelvic radiation for rectal cancer, or prior pelvic radiation for any other malignancy that would prevent the patient from receiving the required radiation treatments for this study. (Patients may receive neoadjuvant chemotherapy prior to study chemoradiation)
•Patients must be \> 18 years of age,
•ECOG performance status 0-1
•Neutrophil Count \>1,000/µl, platelets \>100,000/µl, total bilirubin \< 1.5 x\< ULN ULN (except for patients with Gilbert's syndrome who may only be included if total bilirubin is \< 3xULN with direct bilirubin within normal range), ALT \<2.5xULN, AST \< 2.5xULN, creatinine \<1.5xULN, fasting plasma glucose \< 140 mg/dL and HbA1c \< 6.4% (both criteria have to be met), anemia \> 9.0g/dL.Potassium, Calcium and Magnesium (corrected for albumin) within normal range or \< grade 1 if determined not clinically significant by treating investigator. INR \< 1.5
•Patient is able to swallow and retain oral medication.
•Left ventricular ejection fraction within normal \>50%
•Signed informed consent and is able to comply with study and/or follow- up procedures.
+2 more criteria

Exclusion Criteria

•Patient has a known hypersensitivity to any of the excipients of BYL719 (alpelisib)
•Suspected or confirmed metastatic disease including CNS involvement. For stage IV patients: CNS involvement.
•Patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
•Patient with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BYL719 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). Patients with colostomies are allowed unless colostomy is for one of the precluded reason above.
•Patient who has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
•Patient who has had systemic therapy within 4 weeks of starting study treatment (6 weeks for nitrosoureas or mitomycin C)
•Patient who has undergone major surgery ≤ 4 weeks prior to starting study treatment or in the investigators opinion who has not recovered from side effects of such procedure
•Patient has any of the following cardiac abnormalities: A. symptomatic Congestive heart failure i. history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy ii. Left Ventricular Ejection Fraction (LVEF) \<50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) B. myocardial infarction \< 6 months prior to enrollment C. unstable angina pectoris D. serious uncontrolled cardiac arrhythmia E. symptomatic pericarditis F. QTcF \> 480 msec on the screening ECG (using the QTcF formula)
•Patient who is currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment. To be documented and submitted to BrUOG with registration. Please refer to appendices F and G.
•Patient who has participated in a prior investigational cancer treatment study within 30 days prior to enrollment. This refers to treatment not follow-up.
+16 more criteria

Locations (1)

Rhode Island Hospital and The Miriam Hospital

Providence, Rhode Island, United States

Key Dates

Start Date

June 3, 2016

Primary Completion Date

November 16, 2018

Completion Date

November 16, 2018

Last Updated

March 12, 2021

Enrollment

ACTUAL participants

Conditions

Rectal Cancer

Interventions

BYL719

DRUG

Capecitabine

DRUG

Radiation

RADIATION

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

NCT06696768

Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

View study

RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Resilience and Equity in Aging, Cancer, and Health (REACH)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors