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An Open-Label, Phase I, Dose-Escalation Study of ABR-217620 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 1
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

An Open-Label, Phase I, Dose-Escalation Study of ABR-217620 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

- Patients with histologically or cytologically confirmed advanced NSCLC who have
progressed on first line platin-based therapy or have failed on other treatment
regimens or declined standard regimen.

- ECOG performance status 0 or 1.

- Adequate bone marrow function: absolute neutrophil count greater than or equal to
1500/mm3; WBC greater than or equal to 3000/mm3; platelets greater than or equal to
100,000/mm3; and hemoglobin greater than or equal to 10 g/dL.

- Adequate renal function: creatinine less than or equal to 1.5 x upper limit of normal

- Adequate hepatic function: bilirubin less than ULN; and SGOT (AST) and SGPT (ALT) to
less than 1.5 x ULN concomitant with alkaline phosphatase (ALP) less than 2.5 ULN.

Exclusion Criteria:

- Female patients who are pregnant or nursing or planning to become pregnant during the
study. Fertile, sexually active women not willing to practice reliable contraception.
Male patients with partners of childbearing potential not using acceptable
contraceptive method.

- A serious uncontrolled medical disorder or active infection including unexplained
fever (temperature greater than 100.5 degrees Fahrenheit or 38.1 degrees Celsius)
that would impair the patient's ability to receive study treatment.

- Any concurrent malignancy, except for the following malignancies that may be
included: non-melanoma skin cancer; cervical cancer in situ; ductal carcinoma in
situ (DCIS) or lobular carcinoma in situ (LCIS) of breast; or past history of
prostate cancer without clinical evidence of disease (includes patients receiving
hormonal therapy).

- History of brain metastases, unless stable for more than 4 weeks, and not requiring
steroid therapy and without clinical symptoms of brain metastases.

- Significant symptomatic cardiac disease including history (within past 6 months) or
current unstable angina, congestive heart failure, or myocardial infarction; or
patients with uncontrolled hypertension, or hypertension requiring treatment with
more than 2 drugs.

- History of or current arrhythmias requiring treatment, except for non-specific,
asymptomatic ST-T wave changes or extrasystoles.

- Seizure disorder requiring therapy.

- Treatment with beta-blockers, including topical therapy for glaucoma, during the
6-day treatment period (5-day treatment + 1 day in-patient follow-up), and within 5
days before start of ABR-217620 treatment.

- Simultaneous participation in any other investigational drug study or participation
in a study less than 4 weeks before start of study treatment.

- Treatment with systemic or inhaled corticosteroids within 2 weeks before start of

- Treatment with anticoagulants, except when used to maintain the patency of a central
venous line.

- Active autoimmune disease requiring therapy or any history of systemic lupus
erythematosus or rheumatoid arthritis.

- Concurrent biological response modifiers (within 3 weeks of study entry) except for
any type of erythropoetin.

- Chemo/radio/immunotherapy less than 4 weeks (6 weeks for mitomycin C and
nitrosoureas) before start of treatment.

- Known allergy or hypersensitivity reactions to aminoglycosides (e.g., kanamycin).

- Known allergy or hypersensitivity reactions to docetaxel or other drugs formulated
with polysorbate 80.

- Previous exposure to murine monoclonal antibody (with human anti-mouse antibody
[HAMA] titer above detection limit at baseline) or known hypersensitivity to murine

- Major surgery within 3 weeks.

- Known history of HIV infection.

- Known chronic hepatitis B or C.

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:

Side effect profile (based on blood pressure, body temperature, and laboratory tests)

Outcome Time Frame:

Day 56 (Day 115 if undergo cycles 3/4)

Safety Issue:


Principal Investigator

Suzanne Kilany

Investigator Role:

Study Director

Investigator Affiliation:

Active Biotech AB


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

December 2006

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111