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A Phase 1-2, XIAP Antisense AEG35156 With Weekly Paclitaxel in Patients With Advanced Breast Cancer

30. November 2009 aktualisiert von: Aegera Therapeutics

A Phase 1-2, Multicenter, Open-Label Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With Weekly Paclitaxel in Patients With Advanced Breast Cancer

This is an open-label multicenter, phase 1-2 study. Following determination of the recommended AEG35156 dose in combination with weekly paclitaxel in the initial Phase 1 part of this study, additional patients will be enrolled in the Phase 2 part of the study to assess the activity of the combination in advanced breast cancer.

Studienübersicht

Status

Beendet

Bedingungen

Menschliches Mammakarzinom

Intervention / Behandlung

Arzneimittel: AEG35156

Detaillierte Beschreibung

Breast cancer is the most common cancer in women in the United States, the second most common cause of cancer death, and the main cause of death in women ages 45 to 55. In 2006, 212,920 American women will be diagnosed with breast cancer, and 40,970 will die from this disease.[1]. Fewer than 10 percent of women present with metastatic disease at the time of diagnosis. However, the majority of women who relapse after initial definitive therapy for early stage or locally advanced disease will do so with disseminated metastatic disease rather than an isolated local recurrence. Treatment for metastatic disease is palliative in intent and will usually involve hormone therapy and/or chemotherapy with or without trastuzumab. Active chemotherapy agents include anthracyclines, taxanes, vinorelbine, alkylating agents and antimetabolites. Taxanes have become the cornerstone of first-line treatment for metastatic breast cancer. Weekly doses of paclitaxel can be administered continuously for several weeks with a remarkable lack of myelosuppression [2]. Weekly paclitaxel (80 mg/m2) was directly compared to every three-week therapy (175 mg/m2) in 585 women with metastatic breast cancer. Weekly therapy was associated with a significantly higher response rate (40 versus 28 percent) and longer TTP (nine versus five months), but similar overall survival and worse neurotoxicity [3]. Since patients with metastatic breast cancer are unlikely to be cured of their disease [4], they should be considered candidates for a clinical trial.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

Phase

Phase 2
Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Vereinigte Staaten
- Colorado
  - Denver, Colorado, Vereinigte Staaten, 80218
    - Rocky Mountain Cancer Center
- Florida
  - Ocoee, Florida, Vereinigte Staaten, 34761
    - Cancer Centers of Florida, P.A.
- Indiana
  - Indianapolis, Indiana, Vereinigte Staaten, 46219
    - Central Indiana Cancer Center
- New York
  - Albany, New York, Vereinigte Staaten, 12206
    - New York Oncology & Hematology P. C., Albany Cancer Center
- Ohio
  - Dayton, Ohio, Vereinigte Staaten, 45409
    - Dayton Oncology & Hematology, P.A.
- South Carolina
  - Greenville, South Carolina, Vereinigte Staaten, 29605
    - Cancer Centers of the Carolinas
- Texas
  - Dallas, Texas, Vereinigte Staaten, 75246
    - Sammons Cancer Center
  - Tyler, Texas, Vereinigte Staaten, 75702
    - Tyler Cancer Center
- Virginia
  - Norfolk, Virginia, Vereinigte Staaten, 23502
    - Virginia Oncology Associates
- Washington
  - Vancouver, Washington, Vereinigte Staaten, 98684
    - Northwest Cancer Specialists, P. C.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

Patients with histologically or cytologically confirmed breast adenocarcinoma who are candidates for paclitaxel single agent chemotherapy for metastatic breast cancer
ECOG performance < 2
One or more metastatic tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only)
Life expectancy of at least 6 months
Age > 18 years
Signed, written IRB-approved informed consent
A negative serum pregnancy test (if applicable)
Acceptable liver function:
Bilirubin within normal limit
AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 2.0 times the institution's upper limit of normal
Acceptable renal function:
Serum creatinine within normal limits, OR calculated creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Acceptable hematologic status:
Granulocyte > 1500 cells/uL
Platelet count > 100,000 plt/uL
Hemoglobin > 9.0 g/dL
Acceptable coagulation status:
PT within normal limits
PTT within normal limits
For women of child-bearing potential, the use of effective contraceptive methods during the study
Prior radiotherapy is allowed provided disease progression outside the radiation field has been documented, and treatment completed at least 2 weeks prior to registration

Exclusion Criteria:

Prior taxane chemotherapy for metastatic disease.
More than one prior chemotherapy regimen for metastatic disease
Active progressive brain metastases including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of brain metastases to document the stability of prior lesions
Grade > 2 peripheral neuropathy
Known bleeding diathesis or concurrent treatment with anticoagulants except patients on non-therapeutic line maintenance coumadin
Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Known infection with HIV, hepatitis B, or hepatitis C
Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
Patients who are currently receiving any other investigational agent. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded
Unwillingness or inability to comply with procedures required in this protocol
Any deviation from these inclusion/exclusion criteria must be discussed with the sponsor prior to enrolling patient.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung
Zuteilung: N / A
Interventionsmodell: Einzelgruppenzuweisung
Maskierung: Keine (Offenes Etikett)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Zeitfenster
To determine the recommended dose of AEG35156 when used in combination with weekly paclitaxel and at the dose enhance the clinical benefit rate (CBR) of paclitaxel in patients with advanced breast cancer. Zeitfenster: 2 years	2 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Zeitfenster
Um das progressionsfreie Überleben zu bestimmen. Zeitfenster: 2 Jahre	2 Jahre
To establish the pharmacokinetics of AEG35156 and paclitaxel when used in combination. Zeitfenster: 2 years	2 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aegera Therapeutics

Ermittler

Studienleiter: Jacques Jolivet, MD, FACP, Aegera Therapeutics, Inc.
Hauptermittler: David M Loesch, MD, Central Indiana Cancer Centers

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106.
Greenberg PA, Hortobagyi GN, Smith TL, Ziegler LD, Frye DK, Buzdar AU. Long-term follow-up of patients with complete remission following combination chemotherapy for metastatic breast cancer. J Clin Oncol. 1996 Aug;14(8):2197-205. doi: 10.1200/JCO.1996.14.8.2197.
Perez EA, Vogel CL, Irwin DH, Kirshner JJ, Patel R. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol. 2001 Nov 15;19(22):4216-23. doi: 10.1200/JCO.2001.19.22.4216.
Seidman, A., et al., CALGB 9840: Phase III study of weekly paclitaxel via 1-hour infusion versus standard 3h infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC. Proc Am Soc Clin Oncol, 2004. 23: p. 6s.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2007

Primärer Abschluss (Tatsächlich)

1. Mai 2009

Studienabschluss (Tatsächlich)