Selumetinib in Treating Patients With Locally Advanced or Metastatic Liver Cancer - Study Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer
Interventions:	Drug: selumetinib Other: pharmacological study

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
AZD6244 Treatment	The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a "moderate liver dysfunction" safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort.

Description

AZD6244 Treatment

The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a "moderate liver dysfunction" safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort.

Participant Flow: Overall Study

	AZD6244 Treatment
STARTED	19
COMPLETED	17 ^[1]
NOT COMPLETED	2
Physician Decision	1
Withdrawal by Subject	1

[1]	2 patients failed to complete a full cycle of therapy.

Baseline Characteristics

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Reporting Groups

	Description
AZD6244 Treatment	The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a "moderate liver dysfunction" safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort.

Description

AZD6244 Treatment

The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a "moderate liver dysfunction" safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort.

Baseline Measures

	AZD6244 Treatment
Number of Participants [units: participants]	19
Age [units: participants]
<=18 years	0
Between 18 and 65 years	15
>=65 years	4
Age, Customized [units: years] Mean ( Full Range )	57 ( 48 to 77 )
Gender [units: participants]
Female	6
Male	13
Region of Enrollment [units: participants]
United States	19

Outcome Measures

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1. Primary:

Number of Participants With Radiographic Objective Response (OR) [ Time Frame: 33 weeks ]

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2. Secondary:

Median Progression Free Survival (PFS) [ Time Frame: 33 weeks ]

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3. Secondary:

Median Overall Survival (OS) [ Time Frame: 33 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was stopped at the interim analysis due to lack of radiographic response.

Results Point of Contact:

Name/Title: Bert. H. O'Neil, Associate Professor, Clinical Research
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-4431
e-mail: bert_oneil@med.unc.edu

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00604721 History of Changes
Obsolete Identifiers:	NCT00550719, NCT01656291
Other Study ID Numbers:	NCI-2009-00247, 07-0973, 77782, MCC-07-0973, VU-VICC-GI-0726, GCRC-2625-ORC, MCC-15260, CDR0000571751, N01CM62207, N01CM62208
Study First Received:	January 17, 2008
Results First Received:	June 22, 2012
Last Updated:	May 3, 2013
Health Authority:	United States: Food and Drug Administration