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First in Patient Study for PF-06840003 in Malignant Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02764151
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in patients with malignant gliomas.

Condition or disease Intervention/treatment Phase
Oligodendroglioma Astrocytoma Malignant Glioma Drug: PF-06840003 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06840003 IN PATIENTS WITH MALIGNANT GLIOMAS
Actual Study Start Date : September 9, 2016
Actual Primary Completion Date : December 26, 2018
Actual Study Completion Date : December 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06840003
Daily Oral PF-06840003
Drug: PF-06840003
Daily Oral PF-06840003




Primary Outcome Measures :
  1. Number of participants with Dose Limiting Toxicities (DLTs) [Part 1] [ Time Frame: Baseline through Day 28 ]
    First cycle DLTs in order to determine the maximum tolerated dose

  2. Number of participants with disease control [Part 2] [ Time Frame: Baseline, Week 9 and Week 25 ]
    Disease control rate at 9 and 25 weeks by MRI


Secondary Outcome Measures :
  1. Number of participants with laboratory abnormalities [ Time Frame: Baseline until disease progression or unacceptable toxicity, or up to 12 months ]
  2. Number of participants with vital sign abnormalities [ Time Frame: Baseline until disease progression or unacceptable toxicity, or up to 12 months ]
  3. Number of participants with objective response [ Time Frame: Baseline and every 8 weeks until disease progression, unacceptable toxicity, or up to 12 months ]
  4. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycle 1 Day 1 0, 1, 2, 4, 6, 8, 24 hrs post, Day 4, Day 8, Day 15 0, 1, 2, 4, 6, 8, 24 hr post, Day 1 and Day 15 of subsequent cycles, and up to 12 months ]
  5. Time to reach maximum observed plasma concentration (Tmax) [ Time Frame: Cycle 1 Day 1 0, 1, 2, 4, 6, 8, 24 hrs post, Day 4, Day 8, Day 15 0, 1, 2, 4, 6, 8, 24 hr post, Day 1 and Day 15 of subsequent cycles, and up to 12 months ]
  6. Area Under the Curve from time zero to end of dosing interval (AUCtau) [ Time Frame: Cycle 1 Day 1 0, 1, 2, 4, 6, 8, 24 hrs post, Day 4, Day 8, Day 15 0, 1, 2, 4, 6, 8, 24 hr post, Day 1 and Day 15 of subsequent cycles, and up to 12 months ]
  7. Number of participants with disease control based on the iRANO criteria [ Time Frame: Baseline, Week 9 and Week 25 ]
  8. Plasma kynurenine, tryptophan and kyn/trp ratio [ Time Frame: Cycle 1 Day 1 0, 1, 2, 4, 6, 8, 24 hrs post, Day 4, Day 8, Day 15 0, 1, 2, 4, 6, 8, 24 hr post and at the time of treatment discontinuation ]
  9. Steady state trough level ratio [ Time Frame: Baseline and Day 15 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of WHO Grade IV glioblastoma or WHO Grade III anaplastic gliomas
  • For patients with Grade IV GBM, recurrent disease at the time of the first or second recurrence or progression. For patients with Grade III anaplastic gliomas, recurrent disease at the time of at least a first recurrence but no more than a fourth recurrence or progression
  • Karnofsky performance score greater than or equal to 70%
  • Adequate bone marrow, kidney and liver function

Exclusion Criteria:

  • History of CNS bleeding within 6 months of registration
  • Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months of registration
  • Requires treatment with high dose systemic corticosteroids defined as >2 mg/day
  • Radiation therapy within 12 weeks of registration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764151


Locations
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United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095-6894
UCLA Clinical & Translational Research Center
Los Angeles, California, United States, 90095
UCLA Oncology Center
Los Angeles, California, United States, 90095
UCLA School of Medicine
Los Angeles, California, United States, 90095
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New Mexico
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Columbia University Medical Center
New York, New York, United States, 10019
Columbia University Medical Center
New York, New York, United States, 10032
CUMC Research Pharmacy
New York, New York, United States, 10032
Columbia Doctors Tarrytown
Tarrytown, New York, United States, 10591
United States, North Carolina
Duke Cancer Center
Durham, North Carolina, United States, 27710
Duke University Medical Center, Duke Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02764151     History of Changes
Other Study ID Numbers: C0591001
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Keywords provided by Pfizer:
GBM
malignant glioma
glioma
anaplastic glioma
astrocytoma
IDO
IDO1
PF-06840003

Additional relevant MeSH terms:
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Glioma
Astrocytoma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue