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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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01925274
Pfizer
Terminated
A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Colorectal Cancer
  • Drug: 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.
    Other Name: PKI-587
  • Drug: irinotecan
    90 minutes IV infusion of irinotecan 180mg/m^2 on days 1 and 15 of each cycle
    Other Name: Camptosar, Campto, CPT-11
  • Drug: 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
    Other Name: Erbitux
  • Drug: Irinotecan
    90 minutes IV infusion of Irinotecan 180mg/m^2 on days 1 and 15 of each cycle
    Other Name: Camptosar, Campto, CPT-11
  • Experimental: Arm A
    PF-05212384 plus Irinotecan
    Interventions:
    • Drug: PF-05212384
    • Drug: irinotecan
  • Active Comparator: Arm B
    Cetuximab plus Irinotecan
    Interventions:
    • Drug: Cetuximab
    • Drug: Irinotecan
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
April 2016
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Spain,   United States
Belgium,   Italy
 
NCT01925274
B2151005
2013-002095-40 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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