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A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination With AMG 479 in Subjects With Advanced, Refractory Solid Tumors


Phase 1/Phase 2
16 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Locally Advanced, Metastatic Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Sarcoma, Solid Tumors

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Trial Information

A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination With AMG 479 in Subjects With Advanced, Refractory Solid Tumors


Inclusion Criteria:



- Part 1: Histologically or cytologically confirmed, locally advanced or metastatic,
treatment-refractory solid tumors

- Part 2: Histologically or cytologically confirmed, locally advanced or metastatic:
NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens),
Colorectal Cancer (up to 2 prior treatment regimens), Pancreatic Cancer (up to 1
prior treatment regimen), Ovarian cancer (up to 2 prior treatment regimens), or
Sarcoma (up to 2 prior treatment regimens), according to cohort availability

- Eastern Cooperative Group (ECOG performance status of 0 or 1

- Women or men ≥16 years of age

- Adequate hematology, renal, hepatic, coagulation and glycemic function.

Exclusion Criteria:

- Presence of uncontrolled central nervous system (CNS) disease

- Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved
anticancer proteins/antibodies therapy ≤28 days before enrollment.

- Prior treatment with death receptor agonists (including but not limited to
rhApo2L/TRAIL [AMG951], apomab, mapatumumab, lexatumumab, CS-1008)

- Prior treatment with IGF receptor antagonists (including but not limited to CP-751,
871, MK0646, AVE1642 or IMC-A12)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incedence of dose limiting toxicity

Outcome Time Frame:

Length of Study

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Spain: Spanish Agency of Medicines

Study ID:

20070411

NCT ID:

NCT00819169

Start Date:

January 2009

Completion Date:

October 2011

Related Keywords:

  • Colorectal Cancer
  • Locally Advanced
  • Metastatic Cancer
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Sarcoma
  • Solid Tumors
  • AMG 655
  • AMG 479
  • Apoptosis
  • Monoclonal Antibody
  • Tumor Necrosis Factor
  • Insulin-like Growth Factor
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Sarcoma

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