An Open Label Treatment Extension Study of AMG 706 - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00360867

Purpose

This is an extension study to provide ongoing treatment with AMG 706 monotherapy for subjects with solid tumors who have completed the planned duration of AMG 706 treatment on a separate Amgen protocol and have been evaluated as having stable disease or better. Subjects who are no longer eligible to continue AMG 706 treatment on a separate Amgen protocol (for reasons other than AMG 706 intolerance), but who are receiving clinical benefit or have the potential to receive clinical benefit from AMG 706 per the investigator are also eligible to participate in this trial.

Condition	Intervention	Phase
Solid Tumors	Drug: AMG 706	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Treatment Extension Study of AMG 706

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Motesanib

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Safety (serious adverse events, adverse events, blood pressure and laboratory tests) [ Time Frame: Until objective evidence of disease progression, AMG 706 intolerance, or until loss of clinical benefit ] [ Designated as safety issue: No ]

Enrollment:	94
Study Start Date:	December 2005
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 There are no arms to this study	Drug: AMG 706 The dose of AMG 706 will be administered at the same dose level and schedule received at the conclusion of the previous study but will be no greater than 125 mg QD or 75 mg BID.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women and men 18 yrs or older with solid tumors, previously treated with AMG 706 on an Amgen protocol
Subject must meet one of the following criteria: Subject has completed the planned duration of AMG 706 treatment on a separate Amgen protocol and has been evaluated as having stable disease or better or is no longer eligible to continue AMG 706 treatment on separate Amgen protocol for reasons other than AMG 706 intolerance, but is receiving clinical benefit from AMG 706 in the judgement of the investigator.
Subject must meet one of the following criteria: Subject has received AMG 706 for at least 8 weeks or until the first protocol-specified tumor evaluation (whichever is longer) or
Subject has received at least one dose of AMG 706 but did not receive AMG 706 for =/>8 weeks.
Sign informed consent prior to study specific procedures.

Exclusion Criteria:

Discontinued from prior AMG 706 study due to AMG 706-related adverse event including intolerance to AMG 706 or for any other reason that a subject's safety could be compromised with continued AMG 706 treatment.
Has been off AMG 706 treatment >42 days prior to study day 1.
Participating in any intervening investigational device or drug study between previous AMG 706 study and this AMG 706 study or is receiving any other investigational agent(s) other than AMG 706.
Uncontrolled hypertension (resting blood pressure > 150/90 mmHg). Anti-hypertensive medications are allowed if the subject is stable on their current dose at time of study day1
Requires additional systemic anticancer therapy for primary tumor.
ANC < 1.0 x 10^9/L; PLT < 100 x 10^9/L; Hgb < 9 g/dL; serum creatinine > 2.0 mg/dL or calculated clearance < 40 mL/min; AST >2.5 x ULN, or AST =/> to or =/>5.0 x ULN if secondary to liver metastases; ALT >2.5 x ULN or ALT =/>5X ULN if liver metastasis are present; Alkaline phosphates >2.0 x ULN or =/>5 x ULN if liver and bone metastases are present; total bilirubin =/> 2 x ULN (except for subjects with UGT1A1 promoter polymorphism, ie, Gilbert's syndrome. Subjects enrolled with Gilbert's syndrome must have a total bilirubin <3 x ULN).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360867

Show 44 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050130
Study First Received:	August 3, 2006
Last Updated:	January 7, 2010
ClinicalTrials.gov Identifier:	NCT00360867 History of Changes
Health Authority:	Australia: Human Research Ethics Committee; Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Amgen:

Extension study
solid tumors

ClinicalTrials.gov processed this record on February 08, 2010