- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00360867
An Open Label Treatment Extension Study of AMG 706
September 24, 2015 updated by: Amgen
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Phase 2
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
No
Genders Eligible for Study
All
Description
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).
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Single Arm
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Until objective evidence of disease progression, AMG 706 intolerance, or until loss of clinical benefit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Helpful Links
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
December 1, 2005
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
August 3, 2006
First Submitted That Met QC Criteria
August 4, 2006
First Posted (Estimate)
August 7, 2006
Study Record Updates
Last Update Posted (Estimate)
October 15, 2015
Last Update Submitted That Met QC Criteria
September 24, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20050130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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