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Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC

28. Juli 2016 aktualisiert von: Boehringer Ingelheim

A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer

The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy.

The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

143

Phase

  • Phase 2

Kontakte und Standorte

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

Studienorte

  • Bahamas
      • Nassau, Bahamas
        • 1230.5.00118 Boehringer Ingelheim Investigational Site
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada
        • 1230.5.00104 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Kanada
        • 1230.5.00114 Boehringer Ingelheim Investigational Site
      • Surrey, British Columbia, Kanada
        • 1230.5.00109 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Kanada
        • 1230.5.00107 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Kanada
        • 1230.5.00105 Boehringer Ingelheim Investigational Site
      • Kitchener, Ontario, Kanada
        • 1230.5.00119 Boehringer Ingelheim Investigational Site
      • Oshawa, Ontario, Kanada
        • 1230.5.00116 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Kanada
        • 1230.5.00108 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Kanada
        • 1230.5.00110 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Kanada
        • 1230.5.00102 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Kanada
        • 1230.5.00106 Boehringer Ingelheim Investigational Site

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:

  1. Pathologic or cytologic confirmed diagnosis of NSCLC
  2. Recurrent, advanced or metastatic NSCLC that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)
  3. Patients who are eligible for pemetrexed as second line chemotherapy
  4. Measurable disease by one or more techniques (CT, MRI) according to RECIST
  5. Patients aged 18 years or older
  6. Life expectancy of at least three (3) months
  7. Eastern Cooperative Oncology Group (ECOG) performance Score 0-2
  8. Written informed consent that is consistent with ICH-GCP guidelines and local legislation

Exclusion criteria:

  1. Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
  2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of Cycle 1 of this trial
  3. Any persisting toxicities which are deemed to be clinically significant from the previous therapy
  4. Patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors.
  5. Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
  6. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded.
  7. Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia)
  8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
  9. Patients unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily
  10. Patients who have received prior therapy with pemetrexed
  11. Absolute neutrophil count (ANC) less than 1,500/mm3
  12. Platelet count less than 100,000/mm3
  13. Hemoglobin <90g/L
  14. Total bilirubin >26µmol/L
  15. Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) less than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable
  16. Serum creatinine level >133µmol/L and/or creatinine clearance (measured or calculated) <45 ml/min
  17. Clinically relevant QTc prolongation
  18. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  19. Pregnancy or breast feeding
  20. Known or suspected active alcohol or drug abuse
  21. Patients unable to comply with the protocol
  22. Any known hypersensitivity to the trial drugs or their excipients
  23. Patients with NSCLC of confirmed Squamous histology

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: BI 6727 +pemetrexed
BI 6727 plus 500 mg/^m2 pemetrexed i.v. on day 1 of 21 day cycle
Arzneimittel: pemetrexed
500 mg/m^2 i.v. on day 1 of 21 day cycle
Arzneimittel: BI 6727
BI 6727 i.v. on day 1 of a 21 day cycle
Aktiver Komparator: pemetrexed
500 mg/m^2 i.v. on day 1 of a 21 day cycle
Arzneimittel: pemetrexed
500 mg/m^2 i.v. on day 1 of 21 day cycle

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.
Zeitfenster: From randomization until disease progression or death

Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.

The number of participants analysed displays the number of patients with an event (progression).
From randomization until disease progression or death

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.
Zeitfenster: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Overall Survival (OS)
Zeitfenster: From randomization until time of death
Overall survival (OS) was defined as the duration of time from randomization to time of death.
From randomization until time of death
Duration of Overall Response
Zeitfenster: From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.
From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented
Occurrence and Intensity of AEs Graded According to CTCAE.
Zeitfenster: From first drug infusion until 21 days after last drug infusion, up to 1100 days
All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE).
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Occurence of DLT
Zeitfenster: Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.

Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:

  • treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).
  • treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.
  • CTCAE Grade 4 thrombocytopenia.
Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.
Frequency of Patients With Possible Clinically Significant Abnormalities
Zeitfenster: From first drug infusion until 21 days after last drug infusion, up to 1100 days
Frequency of patients with possible clinically significant abnormalities
From first drug infusion until 21 days after last drug infusion, up to 1100 days
Cmax of Volasertib
Zeitfenster: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Cmax - maximum measured concentration of volasertib in plasma.
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Total Clearance (CL) of Volasertib
Zeitfenster: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
CL - total clearance of volasertib in plasma after IV administration
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Vss of Volasertib
Zeitfenster: 5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Vss - apparent volume of distribution at steady state following IV administration of volasertib
5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion
Cmax of Pemetrexed
Zeitfenster: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Cmax - maximum measured concentration of pemetrexed in plasma
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
CL of Pemetrexed
Zeitfenster: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
CL - total clearance of pemetrexed in plasma after IV administration
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Vss of Pemetrexed
Zeitfenster: 5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion
Vss - apparent volume of distribution at steady state following IV administration of pemetrexed
5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion

Mitarbeiter und Ermittler

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

Sponsor

Boehringer Ingelheim

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

Nützliche Links

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. März 2009

Primärer Abschluss (Tatsächlich)

1. September 2012

Studienabschluss (Tatsächlich)

1. August 2015

Studienanmeldedaten

Zuerst eingereicht

15. Januar 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Januar 2009

Zuerst gepostet (Schätzen)

16. Januar 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

20. September 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juli 2016

Zuletzt verifiziert

1. Juli 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1230.5

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