Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer
Public ClinicalTrials.gov record NCT01347866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-arm Phase 1 Dose Escalation Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of The Dual Pi3k/Mtor Inhibitors Pf-04691502 And Pf-05212384 In Combination With Experimental Or Approved Anticancer Agents In Patients With Advanced Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01347866
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2011
- Primary completion
- Nov 30, 2015
- Completion
- Nov 30, 2015
- Last update posted
- Oct 28, 2018
2011 – 2015
United States locations
- U.S. sites
- 15
- U.S. states
- 3
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095-6984 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| UCLA Oncology Center | Los Angeles | California | 90095 | — |
| Santa Monica - UCLA Medical Center and Orthopaedic Hospital | Santa Monica | California | 90404 | — |
| UCLA Santa Monica Hematology Oncology | Santa Monica | California | 90404 | — |
| Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | — |
| University of Colorado Denver (CTRC) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital Anschutz Inpatient Pavilion | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Medical University of South Carolina, Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| MUSC, Investigational Drug Services | Charleston | South Carolina | 29425 | — |
| MUSC Health East Cooper | Mt. Pleasant | South Carolina | 29464 | — |
| MUSC Specialty Care-North | North Charleston | South Carolina | 29406 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01347866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2018 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01347866 live on ClinicalTrials.gov.