Advertisement

Topics

Cediranib Maleate and Olaparib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

2015-07-16 11:08:23 | BioPortfolio

Summary

This phase II trial studies cediranib maleate in combination with olaparib in treating patients with solid tumors that have spread to other parts of the body or cannot be removed by surgery, including breast cancer, non-small cell lung cancer, small cell lung cancer, and pancreatic cancer. Cediranib maleate and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the flow of oxygen to the tumor, and may help make the tumor more sensitive to olaparib.

Description

PRIMARY OBJECTIVES:

I. To determine the objective response rate (ORR) of cediranib (cediranib maleate) plus olaparib in combination in patients with advanced or metastatic solid tumors of the following tumor types: non-small cell lung cancer (NSCLC), germline breast cancer, early onset 1/2 (BRCA1/2) wild type (wt) triple negative breast cancer (TNBC), pancreatic ductal adenocarcinoma (PDAC), and small cell lung cancer (SCLC). The responses will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability of oral administration of cediranib in combination with olaparib in patients with select advanced solid tumors.

II. To determine progression free survival (PFS) in each tumor cohort.

TERTIARY OBJECTIVES:

I. In the NSCLC cohort of the study, to determine changes in tumor hypoxia on cediranib treatment compared to baseline by positron emission tomography (PET) imaging using [F-18] fluoromisonidazole (F-MISO) as a tracer.

II. To correlate ORR with hypoxia levels at baseline and changes from baseline. III. To determine in tumor tissue, if the BRCA1 gene is repressed or silenced by cediranib treatment and correlate with ORR.

IV. To determine changes in other markers of hypoxia in tumor tissue, correlate with BRCA1 expression and ORR.

V. To correlate hypoxia levels determined by PET imaging with BRCA1 gene expression and hypoxia markers.

VI. To determine baseline levels and changes in angiogenesis markers in plasma, including plasma vascular endothelial growth factor (VEGF) and correlate with ORR and other correlative markers in patients where tissue is available as well as hypoxia levels measured by PET imaging.

VII. To determine changes in microribonucleic acids (miRNAs) related to hypoxia and correlate with ORR and other correlative markers in patients where tissue is available as well as hypoxia levels determined by PET imaging.

VIII. To assess gene variants and mutations in tumors (NSCLC and breast cancer [BC] cohorts) using the BROCA panel to explore, if any variants in genes involved in deoxyribonucleic acid (DNA) damage repair or hypoxia pathways predict ORR and explore correlation with any of the other biomarkers measured in the study.

OUTLINE:

Patients receive cediranib maleate orally (PO) once daily (QD) for 3-4 days and then undergo biopsy. After biopsy, patients continue to receive cediranib maleate PO QD and begin olaparib PO twice daily (BID) beginning on the day after the post-dose biopsy (days 4-7) or by day 8 of course 1 (biopsy cohorts-NSCLC and TNBC) or day 4 of course 1 (non-biopsy cohorts-PDAC and SCLC). Courses repeat every 28 days (35 days for course 1) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Study Design

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

Conditions

Estrogen Receptor Negative

Intervention

18F-Fluoromisonidazole, Cediranib Maleate, Laboratory Biomarker Analysis, Olaparib, Positron Emission Tomography

Location

Yale University Cancer Center LAO
New Haven
Connecticut
United States
06520

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-07-16T11:08:23-0400

Clinical Trials [2402 Associated Clinical Trials listed on BioPortfolio]

Cediranib Maleate and Olaparib Compared to Bevacizumab in Treating Patients With Recurrent Glioblastoma

This randomized phase II trial studies how well cediranib maleate and olaparib work compared to bevacizumab in treating patients with glioblastoma that has come back. Cediranib maleate and...

Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer

This phase II trial studies how well olaparib and cediranib maleate work in treating patients with ovarian, peritoneal, or fallopian tube cancer that has come back (recurrent). Olaparib an...

Olaparib, Cediranib Maleate, and Wee1 Inhibitor AZD1775 in Treating Patients With Recurrent, Refractory, or Metastatic Endometrial Cancer

This randomized phase II trial studies how well olaparib, cediranib maleate, and Wee1 inhibitor AZD1775 work in treating patients with endometrial cancer that has come back, does not respo...

Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer

This randomized phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer. Drugs used in chemotherapy, su...

Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients w...

PubMed Articles [17155 Associated PubMed Articles listed on BioPortfolio]

Optimal timing of fluorine-18-fluoromisonidazole positron emission tomography/computed tomography for assessment of tumor hypoxia in patients with head and neck squamous cell carcinoma.

The aim of this study was to identify the optimal timing of fluorine-18-fluoromisonidazole (F-MISO) PET/CT imaging to assess hypoxia in patients with head and neck squamous cell carcinoma.

Real-World Use and Outcomes of Olaparib: a Population-Based Cohort Study.

Although olaparib, the first poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor approved, has been used in routine clinical practice for over three years, little has been published ...

Olaparib tablets for the treatment of germline BRCA-mutated metastatic breast cancer.

Introduction Germline BRCA mutations (gBRCAm) are diagnosed in approximately 5% of unselected breast cancer patients. Olaparib is a new treatment option for patients with a gBRCAm who have metastatic ...

BRCA Status does not Predict Synergism of a Carboplatin and Olaparib Combination in High-grade Serous Ovarian Cancer Cell Lines.

Over 50% of epithelial ovarian cancers express the BRCAness profile that leads to a dysfunctional homologous recombination repair system. The combination of a dysfunctional homologous recombination re...

Peripheral Blood miR-139 May Serve as a Biomarker for Metabolic Disorders by Targeting FoxO1 and FoxP1.

The current study mainly evaluated whether peripheral blood miR-139 could be used as a biomarker to screen patients with metabolic disorders.

Medical and Biotech [MESH] Definitions

An imaging technique using compounds labelled with short-lived positron-emitting radionuclides (such as carbon-11, nitrogen-13, oxygen-15 and fluorine-18) to measure cell metabolism. It has been useful in study of soft tissues such as CANCER; CARDIOVASCULAR SYSTEM; and brain. SINGLE-PHOTON EMISSION-COMPUTED TOMOGRAPHY is closely related to positron emission tomography, but uses isotopes with longer half-lives and resolution is lower.

An imaging technique that combines a POSITRON-EMISSION TOMOGRAPHY (PET) scanner and a CT X RAY scanner. This establishes a precise anatomic localization in the same session.

A pharmaceutical preparation of brimonidine tartrate and timolol maleate. The combined ADRENERGIC ALPHA2 RECEPTOR AGONIST and ADRENERGIC BETA-ANTAGONIST activity of these drugs reduce INTRAOCULAR PRESSURE in GLAUCOMA patients.

Body of knowledge related to the use of organisms, cells or cell-derived constituents for the purpose of developing products which are technically, scientifically and clinically useful. Alteration of biologic function at the molecular level (i.e., GENETIC ENGINEERING) is a central focus; laboratory methods used include TRANSFECTION and CLONING technologies, sequence and structure analysis algorithms, computer databases, and gene and protein structure function analysis and prediction.

Infiltration of inflammatory cells into the parenchyma of PROSTATE. The subtypes are classified by their varied laboratory analysis, clinical presentation and response to treatment.

More From BioPortfolio on "Cediranib Maleate and Olaparib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial