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Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer

NCT01347866 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2018-10-29

Study results available
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Summary

After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum tolerated doses are identified, further assessment of these combinations will be done in patients with previously treated metastatic colorectal or pancreatic cancer for the PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non small cell lung cancer for the combination of PF-05212384 plus PD-0325901.

Conditions

Interventions

DRUG

PF-05212384

PF-05212384 intravenous infusion weekly starting at 110 mg.

DRUG

PD-0325901

PD-0325901 Oral twice daily (BID) dosing 2 mg BID 3 weeks on 1 week off

DRUG

PF-05212384

PF-05212384 intravenous infusion weekly starting at 95 mg.

DRUG

irinotecan

Irinotecan by intravenous infusion at 180 mg/m2 every two weeks (Q x 2 week)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • Canada
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347866 on ClinicalTrials.gov