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An Open Label Treatment Extension Study of AMG 706

Phase 2
18 Years
Not Enrolling
Solid Tumors

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Trial Information

An Open Label Treatment Extension Study of AMG 706

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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (serious adverse events, adverse events, blood pressure and laboratory tests)

Outcome Time Frame:

Until objective evidence of disease progression, AMG 706 intolerance, or until loss of clinical benefit

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Australia: Human Research Ethics Committee

Study ID:




Start Date:

December 2005

Completion Date:

July 2012

Related Keywords:

  • Solid Tumors
  • Extension study
  • solid tumors