Advertisement

Topics

Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors

2015-06-24 05:53:23 | BioPortfolio

Summary

The goal of this clinical research study is to learn if ilorasertib (ABT-348) can help to control CDKN2A-deficient cancer. The safety of this drug will also be studied.

Description

Study Drug Administration:

Each study cycle is 28 days. You will take ABT-348 by mouth 2 times each day on Days 1, 8, and 15 of each cycle. The first dose you take on these days is called Dose 1, and the second dose you take each day is called Dose 2.

You will take Dose 1 (the earlier dose) of ABT-348 with 4 ounces (about ½ cup) of water. You should fast (not eat or drink anything except water) for 8 hours before taking this dose. You need to fast before this dose because eating food may affect the levels of the study drug that is able to enter your system. You will be allowed to have a light snack 2 hours after Dose 1, and then you may eat anything you like 4 hours after the dose.

You should take Dose 2 (the later dose) as close as possible to 6 hours after the first dose, but not less than 6 hours after the first dose. You do not need to fast before Dose 2. You may eat and drink normally around this dose.

Study Visits:

On Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2:

- You will have a physical exam.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- You will have an EKG (Days 1 and 15 only). After Cycle 3, you will have these EKGs repeated every 3 cycles (Cycles 6, 9, 12, and so on).

On Day 1 of all cycles, urine will be collected for routine tests.

Every 8 weeks, you will have an MRI/CT scan to check the status of the disease.

You may be able to have some of these tests/procedures performed at a local lab, clinic, or doctor's office that is closer to your home. The results of these tests will be sent to the study doctor for review. The study doctor or research staff will discuss this option with you in more detail.

Length of Study Drug Administration:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

You participation on this study will be over after your last dose of study drug.

This is an investigational study. ABT-348 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.

Up to 65 participants will be enrolled in this study. All will take part at MD Anderson.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Cancers

Intervention

Ilorasertib

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-24T05:53:23-0400

Clinical Trials [705 Associated Clinical Trials listed on BioPortfolio]

Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers

This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will en...

Phase I Study of the Combination of Satraplatin and Abraxane in Advanced Cancers

This is a phase I dose escalating study of oral satraplatin in combination with Abraxane administered weekly for three out of every four weeks in patients with advanced solid cancers.

Plasmodium Immunotherapy for Advanced Cancers

The purpose of this study is to evaluate the safety of Plasmodium immunotherapy and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced cancers.The treatment ...

Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression

An open-label, Phase 1/2a study of HPN536 as monotherapy to assess the safety, tolerability and PK in patients with advanced cancers associated with mesothelin expression.

Plasmodium Immunotherapy for Breast and Liver Cancers

The purpose of this study is to evaluate the safety and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced breast cancers and advanced liver cancers.The trea...

PubMed Articles [5809 Associated PubMed Articles listed on BioPortfolio]

Surgery for Locally Advanced GIT Cancers Has Potentially Good Postoperative Outcomes in a Tertiary Hospital.

Adhesions and infiltration into adjacent tissues are present in about 12% of gastrointestinal (GIT) cancers. These adhesions have high potential risk of malignancy. Free resection margin is a predicto...

Therapeutic advances in hormone-dependent cancers: focus on prostate, breast, and ovarian cancers.

Hormonal cancers affect over 400,000 men and women, and contribute collectively to over 100,000 deaths in the United States alone. Thanks to advances in the understanding of these cancers at the molec...

Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial.

Administration of gemcitabine-cisplatin, the current standard therapy for advanced biliary tract cancers, results in median progression-free survival and overall survival of 8.0 and 11.7 months, respe...

Metabolomics workflow for lung cancer: Discovery of biomarkers.

Lung cancer is one of the most common cancers in the world. Due to the limitations of current diagnostic techniques and methods, most lung cancers are diagnosed at the advanced stage, which is not con...

Reconstruction in head-and-neck cancers - analysis of the learning curve.

Oral cancers are some of the most common cancers in India. Most patients present with locally advanced disease requiring extensive resection resulting in large defects. Reconstruction of these defects...

Medical and Biotech [MESH] Definitions

Mucocellular carcinoma of the ovary, usually metastatic from the gastrointestinal tract, characterized by areas of mucoid degeneration and the presence of signet-ring-like cells. It accounts for 30%-40% of metastatic cancers to the ovaries and possibly 1%-2% of all malignant ovarian tumors. The lesions may not be discovered until the primary disease is advanced, and most patients die of their disease within a year. In some cases, a primary tumor is not found. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1685)

Advanced technology that is costly, requires highly skilled personnel, and is unique in its particular application. Includes innovative, specialized medical/surgical procedures as well as advanced diagnostic and therapeutic equipment.

Rare autosomal dominant syndrome characterized by mesenchymal and epithelial neoplasms at multiple sites. MUTATION of the p53 tumor suppressor gene, a component of the DNA DAMAGE response pathway, apparently predisposes family members who inherit it to develop certain cancers. The spectrum of cancers in the syndrome was shown to include, in addition to BREAST CANCER and soft tissue sarcomas (SARCOMA); BRAIN TUMORS; OSTEOSARCOMA; LEUKEMIA; and ADRENOCORTICAL CARCINOMA.

The use of sophisticated methods and equipment to treat cardiopulmonary arrest. Advanced Cardiac Life Support (ACLS) includes the use of specialized equipment to maintain the airway, early defibrillation and pharmacological therapy.

A single-pass transmembrane CELL SURFACE RECEPTOR that binds ADVANCED GLYCOSYLATION END PRODUCTS to mediate cellular responses to both acute and chronic vascular inflammation in conditions such as ATHEROSCLEROSIS and DIABETES MELLITUS, TYPE 2 . It also binds AMYLOID BETA PEPTIDES and the alarmins S100A12 and S100 CALCIUM BINDING PROTEIN BETA SUBUNIT.

More From BioPortfolio on "Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clinical Research Organization
Contract Research Organization (CRO) provide research services outsourced on a contract basis to the pharmaceutical, biotechnology, healthcare and medical device industries: biopharmaceutical development biologic assay development commercial...

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial