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BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour

tiistai 21. elokuuta 2018 päivittänyt: Boehringer Ingelheim

A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumors

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin).

Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

61

Vaihe

  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Belgia
      • Bruxelles, Belgia
        • 1230.6.3201 Boehringer Ingelheim Investigational Site
      • Leuven, Belgia
        • 1230.6.3202 Boehringer Ingelheim Investigational Site

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion criteria:

  1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
  2. Indication for a treatment with platinum therapy as judged by the investigator
  3. Age 18 years or older
  4. Written informed consent consistent with ICH-GCP and local legislation
  5. ECOG performance score lower or equal 2
  6. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)

Exclusion criteria:

  1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
  2. Pregnancy or breastfeeding
  3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II
  4. Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
  5. Second malignancy currently requiring another anti-cancer therapy
  6. ANC less than 1500 / mm3
  7. Platelet count less than 100 000 / mm3
  8. Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome)
  9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
  10. Serum creatinine greater than 1.5 mg / dl (> 132 micromol / L, SI unit equivalent) or creatinine clearance <70ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate)
  11. Known history of relevant QT-prolongation, e.g. long QT-syndrome
  12. Pre-existing clinically relevant hearing loss
  13. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  14. Treatment with other investigational drugs or participation in another clinical interventional trial within the past four weeks before start of therapy or concomitantly with this trial
  15. Systemic anti-cancer therapy or radiotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
  16. Patients unable to comply with the protocol
  17. Active alcohol or drug abuse

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: A. BI 6727-cisplatin
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin
Lääke: BI 6727
low to high dose
Kokeellinen: B. BI 6727-carboplatin
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin
Lääke: BI-6727
Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Maximum Tolerated Dose
Aikaikkuna: 3 weeks

The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin.

0=not maximum tolerated dose, 1=was maximum tolerated dose.
3 weeks

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With Dose Limiting Toxicities
Aikaikkuna: 3 weeks
Percentage of participants with dose limiting toxicities (DLTs) during the first treatment cycle.
3 weeks
Objective Response Rate
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Objective response was defined as the proportion of participants having at least a best response of complete response (CR) or partial response (PR) determined based on RECIST criteria, version 1.0 (V1.0).

Tumour response was documented using appropriate techniques
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Objective Response
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Duration of objective response was defined as the time from first documented confirmed complete response (CR) or partial response (PR) to first evidence of progressive disease (PD) or death from any cause, whichever occurred first, determined based on RECIST V1.0 criteria.

Tumour response was documented using appropriate techniques
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Best Overall Response
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Best overall response was defined as the best response obtained since the start of study treatment until disease progression, determined based on RECIST V1.0 criteria.
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Disease Control Rate
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of participants with confirmed disease control, defined as the proportion of patients with a best overall response of at least stable disease (SD), determined based on RECIST V1.0 criteria.
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Disease Control
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Duration of Disease control was defined as the time from the start of study treatment to the time of disease progression or death, whichever occurred first.
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Progression-free Survival
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Progression-free survival based on RECIST V1.0 criteria was defined as the time from start of treatment to the date of evidence of progressive disease (PD) or death from any cause, whichever occurred first.
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Incidence and Intensity of Adverse Events According to CTCAE Version 3.0
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Incidence and intensity of adverse events according to common terminology criteria for adverse events (CTCAE) version 3.0
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of Participants With Serious Adverse Events
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of participants with serious adverse events (AEs)
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Percentage of Participants With Significant Adverse Events
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with significant adverse events (AEs): dose limiting toxicity (DLT) was defined as significant AE.

DLTs (i.e. significant AEs) per protocol were:

  • drug related CTCAE grade 3 or 4 non haematological toxicity (except vomiting or diarrhoea responding to supportive treatment and ototoxicity)
  • drug related CTCAE grade 4 neutropenia for seven or more days and / or complicated by infection
  • drug related CTCAE Grade 4 thrombocytopenia
  • drug related febrile neutropenia grade 3 (ANC<1000/mm³ and fever≥ 38.5°C)
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Total Plasma Clearance After Intravascular Administration (CL)
Aikaikkuna: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Total plasma clearance after intravascular administration (CL) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss)
Aikaikkuna: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Apparent volume of distribution at steady state following intravascular administration (Vss) of Volasertib in combination with cisplatin or carboplatin during treatment cycle 1.
1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion
Change From Baseline in Pulse Rate
Aikaikkuna: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change from baseline in pulse rate at last value on treatment
Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change From Baseline in Neutrophils
Aikaikkuna: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change from baseline in neutrophils with the maximum value on treatment
Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change From Baseline in Platelets
Aikaikkuna: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Change from baseline in platelets with the maximum value on treatment
Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of participants (%) with possible clinically significant abnormalities for neutrophils: : defined as neutrophils >=CTCAE grade 2 (CTCAE v3.0), with worsening from baseline. The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Frequency of participants (%) with possible clinically significant abnormalities for platelets : defined as platelets >=CTCAE grade 2 (based on CTCAE v3.0), with worsening from baseline.

The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on last value on treatment.

Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on last value on treatment.

Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for platelets based on worst value on treatment.

Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Percentage of participants with transitions relative to the baseline CTC grade (version 3) for neutrophils based on worst value on treatment.

Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE)
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst CTCAE Grade on Treatment for Platelets
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for platelets (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst CTCAE Grade on Treatment for Neutrophils
Aikaikkuna: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days
Worst Common terminology criteria for adverse events (CTCAE) grade on treatment for neutrophils (CTC version 3). The CTCAE scale measures the severity of adverse events which goes from 1 (mild AE) to 5 (death related AE).
From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Boehringer Ingelheim

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Lauantai 1. elokuuta 2009

Ensisijainen valmistuminen (Todellinen)

Tiistai 1. marraskuuta 2011

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. helmikuuta 2012

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 31. elokuuta 2009

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 31. elokuuta 2009

Ensimmäinen Lähetetty (Arvio)

Tiistai 1. syyskuuta 2009

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 31. tammikuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 21. elokuuta 2018

Viimeksi vahvistettu

Keskiviikko 1. elokuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muut tutkimustunnusnumerot

  • 1230.6
  • 2008-003926-40 (EudraCT-numero: EudraCT)

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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