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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

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Irinotecan
Drug: PF-05212384
Drug: irinotecan
Drug: Cetuximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01925274
2013-002095-40 (EudraCT Number)
B2151005

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

19 participants in 2 patient groups

Arm A
Experimental group
Description:
PF-05212384 plus Irinotecan
Treatment:
Drug: irinotecan
Drug: PF-05212384
Arm B
Active Comparator group
Description:
Cetuximab plus Irinotecan
Treatment:
Drug: Irinotecan
Drug: Cetuximab

Trial contacts and locations

30

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Data sourced from clinicaltrials.gov

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