ABR-217620 in Combination With Docetaxel in Patients With Advanced Non-small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132379
• Other study ID #: 05762003
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2005
• Last updated: August 26, 2014
• Start date: November 2005
• Est. completion date: December 2006

Study information

• Verified date: August 2014
• Source: Active Biotech AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines AgencyRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug, in combination with docetaxel (an approved drug for treating non-small cell lung cancer [NSCLC]), can be given to patients with NSCLC without causing unacceptable side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (ULN).

• 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.

• 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 proteins.

• Major surgery within 3 weeks.

• Known history of HIV infection.

• Known chronic hepatitis B or C.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• ABR-217620
10.3, 16.5 or 22 mcg/kg, IV, daily 5 minute bolus injection for 4 consecutive day per cycle; up to 6 cycles
• docetaxel
75mg/m^2, IV, single 60 minute infusion, beginning on Day 5 then every third week

Locations

Country	Name	City	State
Denmark	Onkologisk Klinik, Rigshospitalet	Copenhagen
Russian Federation	City Multifield Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery	St. Petersburg
Russian Federation	St. Petersburg Pavlov State Medical University	St. Petersburg
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Active Biotech AB

Countries where clinical trial is conducted

United States,  Denmark,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effect profile (based on blood pressure, body temperature, and laboratory tests)		Day 56 (Day 115 if undergo cycles 3/4)	Yes
Secondary	Pharmacokinetic parameters		Days 1 and 4 of cycles 1 and 2	No
Secondary	Immunological response		Day 56 (Day 115 if undergo cycles 3/4)	Yes
Secondary	Changes in anti-SEA/E-120 levels		Day 56 (Day 115 if undergo cycles 3/4)	Yes
Secondary	Objective response rate		Day 56 (Day 115 if undergo cycles 3/4)	No
Secondary	Time to progression and Survival		Followed for up to 1 year	No