A Phase 1 Study of ARRY-438162 in Patients With Advanced Solid Tumors Followed by an Expansion Cohort in Patients With Advanced or Metastatic Biliary Cancer

2014-08-27 03:20:02 | BioPortfolio


This is the first part of a 2-part study to assess the safety, tolerability, and pharmacokinetics of ARRY-438162 in patients with advanced solid tumors. This first part is an open-label dose escalation study to establish the maximum tolerated dose of ARRY-438162.

The second part, expansion at maximum tolerated dose (MTD), is designed to assess the safety, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics (PD) in patients with advanced or metastatic biliary cancer. Approximately 30 patients from the US will be enrolled in Part 1 and approximately 25 patients from the US will be enrolled in Part 2.

Study Design

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


Advanced Solid Tumors




University of California, Los Angeles
Los Angeles
United States




Array BioPharma

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:20:02-0400

Clinical Trials [2778 Associated Clinical Trials listed on BioPortfolio]

A Phase I Study to Assess the Safety, and Effect of Food on Pharmacokinetics of the ARRY-334543 Tablet Formulation Given Twice-Daily in Patients With Advanced Solid Tumors

This is a dose escalation study of ARRY-334543 being conducted to evaluate the tolerability, drug levels and food-effect of the tablet formulation in patients with advanced solid tumors.

A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

This is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in ad...

ARRY-334543 With Docetaxel in Advanced Solid Tumors

This is a dose-escalation study to test the safety of ARRY-334543 given with docetaxel in patients with cancer.

Orally Active, Small Molecule Inhibitor of MEK1 and MEK2 in Patients With Active Rheumatoid Arthritis

This is a Phase 2, randomized, double-blind, multicenter, placebo-controlled, parallel-group, 12-week treatment trial of a MEK inhibitor with oral delivery in patients with active RA on st...

Phase I Safety and Pharmacokinetic Study of ARRY-520 in Solid Tumors

ARRY-520 is designed to prevent cancer cells from reproducing. By preventing the tumor cells from reproducing, ARRY-520 may slow the spread of the cancer cells and may cause them to die. N...

PubMed Articles [9170 Associated PubMed Articles listed on BioPortfolio]

Phase I study of the anti-α5β1 monoclonal antibody MINT1526A with or without bevacizumab in patients with advanced solid tumors.

MINT1526A is a monoclonal antibody that blocks the interaction of integrin alpha 5 beta 1 (α5β1) with its extracellular matrix ligands. This phase I study evaluated the safety and pharmacokinetics o...

Epacadostat Plus Pembrolizumab in Patients With Advanced Solid Tumors: Phase I Results From a Multicenter, Open-Label Phase I/II Trial (ECHO-202/KEYNOTE-037).

Tumors may evade immunosurveillance through upregulation of the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme. Epacadostat is a potent and highly selective IDO1 enzyme inhibitor. The open-label phase I/...

Microsatellite Instability Is Associated With the Presence of Lynch Syndrome Pan-Cancer.

Microsatellite instability (MSI) and/or mismatch repair deficiency (MMR-D) testing has traditionally been performed in patients with colorectal (CRC) and endometrial cancer (EC) to screen for Lynch sy...

The clinicopathological and prognostic value of long non-coding RNA ZEB1-AS1 in solid tumors: A meta-analysis.

Studies have reported that Zinc finger E-box binding homeobox 1 antisense 1 (ZEB1-AS1) is overexpressed in many malignant tumors. However, the sample size in those studies was limited, so the clinicop...

Animal Models for Studying Tumor Microenvironment (TME) and Resistance to Lymphocytic Infiltration.

In cancer immunotherapy, cytotoxic T or NK cells need to engage cancer cells to initiate the killing. However, in clinical studies and in mouse models, some solid tumors are found with no lymphocytes....

Medical and Biotech [MESH] Definitions

An alkylating agent of value against both hematologic malignancies and solid tumors.

An internationally recognized set of published rules used for evaluation of cancer treatment that define when tumors found in cancer patients improve, worsen, or remain stable during treatment. These criteria are based specifically on the response of the tumor(s) to treatment, and not on the overall health status of the patient resulting from treatment.

A smooth, solid or cystic fibroepithelial (FIBROEPITHELIAL NEOPLASMS) tumor, usually found in the OVARIES but can also be found in the adnexal region and the KIDNEYS. It consists of a fibrous stroma with nests of epithelial cells that sometimes resemble the transitional cells lining the urinary bladder. Brenner tumors generally are benign and asymptomatic. Malignant Brenner tumors have been reported.

A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2. It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors.

B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.

More From BioPortfolio on "A Phase 1 Study of ARRY-438162 in Patients With Advanced Solid Tumors Followed by an Expansion Cohort in Patients With Advanced or Metastatic Biliary Cancer"

Quick Search


Relevant Topics

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...

A diagnostic test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example: to diagnose diseases to measure the progress or recovery from disease to confirm that a person is free from disease Clin...

Searches Linking to this Trial