Study of XL647 Administered Orally Daily to Patients With Solid Tumors

May 9, 2022 updated by: Kadmon Corporation, LLC

A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors

The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.

Study Overview

Status

Completed

Conditions

Cancer

Intervention / Treatment

Drug: XL647

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Stanford, California, United States, 94305
    - Stanford University Medical Center
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subject has histologically confirmed malignancy that is metastatic or unresectable
Subject has disease that is assessable by tumor marker, physical, or radiologic means
Subject is at least 18 years old
Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
Subject has a life expectancy ≥ 3 months
Subject has normal organ and marrow function
Subject gives written informed consent
Subject must use an accepted method of contraception during the study
Female subjects of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

Subject has received anticancer treatment within 30 days of first dose of XL647
Subject has received another investigational agent within 30 days of first dose of XL647
Subject has known brain metastases
Subject has corrected QT interval (QTc) of > 0.45 seconds
Subject is currently receiving anticoagulation therapy with warfarin
Subject has uncontrolled intercurrent illness
Subject is pregnant or breastfeeding
Subject has known HIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate safety, tolerability, and maximum tolerated dose of XL647 Time Frame: Inclusion until 30 days post last treatment	Inclusion until 30 days post last treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterize pharmacokinetics and pharmacodynamic effects of XL647 Time Frame: At various time points from pre-dosing until post dosing	At various time points from pre-dosing until post dosing
Evaluate preliminary tumor response Time Frame: Inclusion until disease progression	Inclusion until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kadmon Corporation, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Das M, Padda SK, Frymoyer A, Molina J, Adjei A, Lensing JL, Miles D, Sikic BI, Wakelee HA. A safety, tolerability, and pharmacokinetic analysis of two phase I studies of multitargeted small molecule tyrosine kinase inhibitor XL647 with an intermittent and continuous dosing schedule in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2018 Sep;82(3):541-550. doi: 10.1007/s00280-018-3646-0. Epub 2018 Jul 20.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 12, 2006

First Submitted That Met QC Criteria