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A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

keskiviikko 19. joulukuuta 2018 päivittänyt: Pfizer

A RANDOMIZED PHASE 2 STUDY OF PF-05212384 PLUS IRINOTECAN VERSUS CETUXIMAB PLUS IRINOTECAN IN PATIENTS WITH KRAS AND NRAS WILD TYPE METASTATIC COLORECTAL CANCER

This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

19

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

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

Opiskelupaikat

  • Espanja
      • Madrid, Espanja, 28009
        • Hospital General Universitario Gregorio Marañón
  • Japani
    • Aichi
      • Nagoya, Aichi, Japani, 464-8681
        • Aichi cancer center central hospital
    • Chiba
      • Kashiwa, Chiba, Japani, 277-8577
        • National Cancer Center Hospital East
  • Korean tasavalta
      • Seoul, Korean tasavalta, 135-710
        • Samsung Medical Center
      • Seoul, Korean tasavalta, 138-736
        • Asan Medical Center
      • Seoul, Korean tasavalta, 110-744
        • Seoul National University Hospital / Department of Internal Medicine
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korean tasavalta, 410-769
        • National Cancer Center
  • Yhdysvallat
    • California
      • Bakersfield, California, Yhdysvallat, 93309
        • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
      • Los Angeles, California, Yhdysvallat, 90095-7349
        • UCLA West Medical Pharmacy
      • Los Angeles, California, Yhdysvallat, 90095
        • Regulatory Management only: TRIO-US Central Administration
      • Los Angeles, California, Yhdysvallat, 90095-7349
        • Drug Management Only: UCLA West Medical Pharmacy
      • Los Angeles, California, Yhdysvallat, 90095
        • TRIO_US
      • Los Angeles, California, Yhdysvallat, 90095-7349
        • Drug Management Only: UCLA West Medical Pharmacy, Att: Steven L Wong, Pharm D
      • Los Angeles, California, Yhdysvallat, 90095
        • TRIO-US Central Administration (Regulatory Management only)
      • Northridge, California, Yhdysvallat, 91328
        • West Valley Hematology/Oncology Med Group
    • Missouri
      • Creve Coeur, Missouri, Yhdysvallat, 63141
        • Siteman Cancer Center - West County
      • Saint Louis, Missouri, Yhdysvallat, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Yhdysvallat, 63110
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, Yhdysvallat, 63129
        • Siteman Cancer Center - South County
      • Saint Peters, Missouri, Yhdysvallat, 63376
        • Siteman Cancer Center - St Peters
    • Nevada
      • Henderson, Nevada, Yhdysvallat, 89074
        • Comprehensive Cancer Centers of Nevada
      • Henderson, Nevada, Yhdysvallat, 89052
        • Comprehensive Cancer Centers of Nevada
      • Henderson, Nevada, Yhdysvallat, 89014
        • Regulatory Office: Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Yhdysvallat, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Yhdysvallat, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Yhdysvallat, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Buffalo, New York, Yhdysvallat, 14263
        • Roswell Park Cancer Institute
    • Washington
      • Kennewick, Washington, Yhdysvallat, 99336
        • Kadlec Clinic Hematology and Oncology
      • Richland, Washington, Yhdysvallat, 99352
        • Kadlec Medical Center
      • Richland, Washington, Yhdysvallat, 99352
        • Outpatient Imaging Center
      • Spokane, Washington, Yhdysvallat, 99208
        • Medical Oncology Associates, PS
      • Spokane Valley, Washington, Yhdysvallat, 99216
        • Spokane Valley Cancer Center

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:

  • KRAS and NRAS wild type metastatic colorectal cancer
  • Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
  • Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2
  • At least one measurable lesion by Response Evaluation Criterion in Solid Tumors [RECIST]

Exclusion Criteria:

  • More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
  • Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
  • Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
  • Prior radiation to the pelvis or abdomen
  • Patients with history of interstitial lung disease.

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: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Arm A
PF-05212384 plus Irinotecan
Lääke: PF-05212384
30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle. Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability.
Muut nimet:
  • PKI-587
Lääke: irinotecan
90 minutes IV infusion of irinotecan 180mg/m^2 on days 1 and 15 of each cycle
Muut nimet:
  • Camptosar, Campto, CPT-11
Active Comparator: Arm B
Cetuximab plus Irinotecan
Lääke: Cetuximab
120 minute IV infusion of cetuximab 400mg/m^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1
Muut nimet:
  • Erbitux
Lääke: Irinotecan
90 minutes IV infusion of Irinotecan 180mg/m^2 on days 1 and 15 of each cycle
Muut nimet:
  • Camptosar, Campto, CPT-11

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Progression Free Survival (PFS) as Assessed by Investigators
Aikaikkuna: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Progression-free survival (PFS) was the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Median PFS was estimated based on the Kaplan-Meier method.
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Unacceptable Toxicity in Cycle 1 (Japanese LIC Only)
Aikaikkuna: 28 days
Unacceptable toxicity (according to Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0) was any of the following occurrences: (1) Grade 4 neutropenia >7 days, or febrile neutropenia, or Grade 4 thrombocytopenia; (2) Grade >=3 nausea/vomiting despite optimal antiemetic treatment, or Grade >=3 diarrhea despite optimal anti diarrheal treatment; (3) unmanageable Grade >=3 hyperglycemia; (4) mean QTc interval (time from electrocardiogram [ECG] Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate) >501 msec in triplicate 12-lead ECG, or myocardial infarction, or ventricular arrhythmia; (5) Grade >=3 non-hematologic toxicity; (6) treatment delay of >=2 weeks due to study drug related toxicity; (7) persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses of both PF-05212384 and irinotecan during Cycle 1; (8) Grade >=2 respiratory toxicities.
28 days
Percentage of Participants With Objective Response
Aikaikkuna: 2 years
Percentage of participants with objective response was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1. Confirmed PR was defined as disappearance of all target lesions. Confirmed PR was defined as >=30% decrease in sum of the longest dimensions of the target lesions taking the baseline sum as a reference. Confirmed responses were those that persisted on repeat imaging study >=4 weeks after initial documentation of response.
2 years
Duration of Response
Aikaikkuna: 2 years
For participants with an objective response (CR or PR), duration of response was defined as the time from first documentation of CR or PR to date of first documentation of objective progression or death. Date of first documentation of progression and date of first documentation of CR or PR were based on Investigator's assessment of response.
2 years
Overall Survival (OS)
Aikaikkuna: 2 years
Overall survival (OS) was defined as the duration from enrollment to death. Participants last known to be alive were censored at date of last contact.
2 years
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Aikaikkuna: Administration of the first dose of study drug through 28 calendar days after the last administration of study drug
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE was defined as any untoward occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. AEs included both serious and non-serious AEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study drug.
Administration of the first dose of study drug through 28 calendar days after the last administration of study drug
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) Grade
Aikaikkuna: Administration of the first dose of study drug through 28 calendar days after the last administration of study drug
TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. CTCAE version 4.0 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.
Administration of the first dose of study drug through 28 calendar days after the last administration of study drug
Number of Participants With Laboratory Test (Hematology) Abnormalities
Aikaikkuna: 2 years
The following hematology parameters were evaluated in this study: hemoglobin, white blood cells (WBC) with differential, and platelets.
2 years
Number of Participants With Laboratory Test (Chemistry) Abnormalities
Aikaikkuna: 2 years
The following chemistry parameters were evaluated in this study: sodium, potassium, magnesium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, albumin, blood urea nitrogen (BUN) or urea, creatinine, total calcium, glycosylated hemoglobin (HbA1c), glucose, uric acid, phosphorus or phosphate, insulin, and C-peptide.
2 years
Number of Participants With Laboratory Test (Urinalysis) Abnormalities
Aikaikkuna: 2 years
Urinalysis included urine dipstick for protein and blood: if positive, perform a microscopic analysis. Number of participants with urine protein tested positive is presented.
2 years
Number of Participants With Laboratory Test (Coagulation) Abnormalities
Aikaikkuna: 2 years
Coagulation analysis included partial thromboplastin time (PTT) and international normalized ratio (INR) or prothrombin time (PT).
2 years
Number of Participants With ECG Post-Baseline Maximum Absolute Values Meeting Pre-defined Criteria
Aikaikkuna: 2 years
The number of participants with ECG post-baseline maximum absolute values meeting the following criteria was reported: (1) maximum QTc interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (2) maximum QTcB (QT corrected for heart rate using Bazett's formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (3) maximum QTcF (QT corrected for heart rate using Fridericia's formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec.
2 years
Number of Participants With ECG Maximum Increase From Baseline Meeting Pre-defined Criteria
Aikaikkuna: 2 years

The number of participants with ECG maximum increase from baseline meeting the following criteria was reported:

Criterion A: maximum QTc interval increase from baseline >30 msec and ≤60 msec; criterion B: maximum QTc interval increase from baseline >60 msec; criterion C: maximum QTcB interval increase from baseline >30 msec and ≤60 msec; criterion D: maximum QTcB interval increase from baseline >60 msec; criterion E: maximum QTcF interval increase from baseline >30 msec and ≤60 msec; criterion F: maximum QTcF interval increase from baseline >60 msec.
2 years
Maximum Plasma Concentration (Cmax) of PF-05212384
Aikaikkuna: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
Cmax of PF-05212384 was observed directly from data.
Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
Maximum Plasma Concentration (Cmax) of Irinotecan
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Cmax of irinotecan was observed directly from data.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Maximum Plasma Concentration (Cmax) of SN-38
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
SN-38 is an irinotecan metabolite. Cmax of SN-38 was observed directly from data.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Time for Maximum Plasma Concentration (Tmax) of PF-05212384
Aikaikkuna: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
Tmax of PF-05212384 was observed directly from data as time of first occurrence.
Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
Time for Maximum Plasma Concentration (Tmax) of Irinotecan
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Tmax of irinotecan was observed directly from data as time of first occurrence.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Time for Maximum Plasma Concentration (Tmax) of SN-38
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
SN-38 is an irinotecan metabolite. Tmax of SN-38 was observed directly from data as time of first occurrence.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Terminal Elimination Half Life (t½) of PF-05212384
Aikaikkuna: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.
Terminal Elimination Half Life (t½) of Irinotecan
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Terminal Elimination Half Life (t½) of SN-38
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of PF-05212384
Aikaikkuna: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.
AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of PF-05212384 was determined using linear/log trapezoidal method.
Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.
Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of Irinotecan
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of irinotecan was determined using linear/log trapezoidal method.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of SN-38
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of SN-38 (an irinotecan metabolite) was determined using linear/log trapezoidal method.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05212384
Aikaikkuna: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.
AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of PF-05212384 was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.
Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Irinotecan
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of irinotecan was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of SN-38
Aikaikkuna: Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of SN-38 (an irinotecan metabolite) was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.
Levels of Signaling Proteins in Paired and Single Tumor Biopsies
Aikaikkuna: 2 years
Pre defined signaling proteins included Akt (protein kinase B), p-Akt (phosphorylated Akt), p-S6 (phosphorylated ribosomal protein S6), p-Met (phosphorylated Met, a receptor tyrosine kinase), p-mTOR (phosphorylated mammalian target of rapamycin), EGFR (epithelial growth factor receptor), and p-EGFR (phosphorylated EGFR).
2 years
Number of Participants With Expression of Pre-defined Gene Sequences in Biopsied Tumor Tissues
Aikaikkuna: 2 years
Pre-defined gene sequences were those related to EGFR, PI3K (phosphoinositide-3 kinase) and other oncogenic pathways; examples included but were not limited to PIK3CA (this gene encodes the catalytic subunit of PI3K), PIK3R1 (this gene encodes the regulatory subunit of PI3K), KRAS, NRAS and BRAF (this gene encodes serine/threonine-protein kinase B-Raf) sequences and PIK3CA gene amplification. Due to early termination of this study, these pre-defined gene sequences were not analyzed, except for KRAS and NRAS. Number of participants who had KRAS and NRAS wild type status confirmed by the central laboratory is presented.
2 years
Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
Aikaikkuna: 2 years
Functional Assessment of Cancer Therapy-Colorectal (FACT-C) was used in this study to assess Health-Related Quality of Life (HRQoL) and CRC-related symptoms in participants enrolled to the randomized portion of the study. The FACT-C is part of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system, a comprehensive and extensive set of self-reported instruments for the assessment of health-related quality of life in participants with cancer or other chronic illnesses.
2 years

Yhteistyökumppanit ja tutkijat

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Sponsori

Pfizer

Julkaisuja ja hyödyllisiä linkkejä

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

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 (Todellinen)

Perjantai 15. marraskuuta 2013

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 6. huhtikuuta 2016

Opintojen valmistuminen (Todellinen)

Keskiviikko 6. huhtikuuta 2016

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 15. elokuuta 2013

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 15. elokuuta 2013

Ensimmäinen Lähetetty (Arvio)

Maanantai 19. elokuuta 2013

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 8. tammikuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 19. joulukuuta 2018

Viimeksi vahvistettu

Lauantai 1. joulukuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • B2151005
  • 2013-002095-40 (EudraCT-numero)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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