Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)

A Phase II Single-Arm Study Evaluating the Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)

Sponsoren

Hauptsponsor: Abbott

Quelle Abbott
Kurze Zusammenfassung

The primary objective of this Phase II study is to assess the safety, pharmacokinetics and effectiveness of ABT-510 in combination with standard carboplatin/paclitaxel chemotherapy in subjects with stage IIIb or IV NSCLC.

Gesamtstatus Terminated
Anfangsdatum March 2003
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Progression free survival One year
Sekundäres Ergebnis
Messen Zeitfenster
Overall survival One year
Response rate One year
Einschreibung 25
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: ABT-510/Thrombospondin-1 mimetic

Interventionsart: Drug

Interventionsname: Carboplatin/Taxol

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria

- The subject is at least 18 years of age.

- The subject has histologically or cytology documented Stage IIIB with pleural effusion or Stage IV NSCLC. The subject must have measurable disease (RECIST Criteria for Tumor Response).

- The subject has not received first line therapy for treatment of NSCLC.

- The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.

- The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.

- The subject is able to self-administer or has a caregiver who can reliably administer SC injections.

- The subject must have adequate bone marrow, renal and hepatic function as follows:

- Bone marrow: White blood cell count (WBC) >= 3,000/mm3; Platelets; >= 100,000/mm3; Hemoglobin >= 9.0 g/dL;

- Renal function: Serum creatinine <= 2.0 mg/dL;

- Hepatic function: Bilirubin <= 1.5 mg/dL; AST and ALT <= 1.5 X the upper normal limit (ULN); unless liver metastases are present, then AST and ALT <= 5.0 x ULN.

- The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Exclusion Criteria

- The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.

- The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.

- The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks from Study Day 1) or currently exhibits other clinically significant events of bleeding.

- The subject has received investigational therapy within four weeks prior to study drug administration.

- The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.

- The subject has previous or current malignancies at other sites, with the exception of: Adequately treated in situ carcinoma of the cervix uteri; Basal or squamous cell carcinoma of the skin; Previous nonpulmonary malignancy confined and surgically resected with no evidence of active malignancy.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Global Medical Information 1-800-633-9110 Study Director Abbott
Ort
Einrichtung:
Oncology-Hematology Group of South Florida | Miami, Florida, 33176, United States
University of Chicago | Chicago, Illinois, 60637-1470, United States
The West Cancer Clinic | Memphis, Tennessee, 38120, United States
University of Wisconsin | Madison,, Wisconsin, 53792-5666, United States
Standort Länder

United States

Überprüfungsdatum

August 2007

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov