A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Collaborators:
Roswell Park Cancer Institute
South Texas Accelerated Research Therapeutics (START)
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00728468
First received: July 31, 2008
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
Research in test tubes suggests that may affect cytochrome P450 2D6 (CYP2D6), an important enzyme that is responsible for eliminating many drugs that cancer patients need to take, including dextromethorphan. The purpose of this study is to test the impact of PF-00299804 on the activity of CYP2D6, and how the human body handles dextromethorphan.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Malignant Solid Tumors |
Drug: PF-00299804 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Phase 1, Open Label, Single Arm Trial To Evaluate The Effect Of PF- 00299804 On The Pharmacokinetics Of Dextromethorphan In Patients With Advanced Malignant Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Plasma pharmacokinetic parameters of dextromethorphan and dextrorphan (AUCTlast, AUCinf, Cmax, Tmax, and t1/2; oral clearance for dextromethorphan only) [ Time Frame: 17-APR-2010 ] [ Designated as safety issue: No ]
- Plasma dextromethorphan: dextrorphan AUC ratios, and urinary dextromethorphan : dextrorphan ratios [ Time Frame: 17-APR-2010 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety in patients when study drugs are given alone or co administered will be characterized by type, frequency, severity [as graded by NCI CTCAE v.3.0], timing and relationship to study treatment of adverse events and laboratory abnormalities observed [ Time Frame: 17-APR-2010 ] [ Designated as safety issue: Yes ]
- Best overall response as measured using the Response Evaluation Criteria in Solid Tumors (RECIST), Time to Progression (TTP), and Duration of Response (DR). [ Time Frame: 17-APR-2010 ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | May 2013 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment arm |
Drug: PF-00299804
PF-00299804: Patients take oral 45 mg PF-00299804 once daily starting on Cycle 1 Day 1 until disease progression or unacceptable toxicities occur. One cycle equals 21 days. Dextromethorphan: Patient take a single 30 mg oral dose of dextromethorphan HBr three days prior to Cycle 1 Day 1, and then on Cycle 2 Day 7. |
Detailed Description:
To assess the effect of repeated dosing with 45 mg QD PF-00299804 on the pharmacokinetics of dextromethorphan, a CYP2D6 probe, in cancer patients with advanced malignant solid tumors.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with a histologically or cytologically confirmed advanced malignant solid tumor for which there is no currently approved treatment or which is unresponsive to currently approved therapies;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Patients with performance status 2 could be eligible upon agreement between sponsors and investigators;
- Adequate bone marrow, renal, liver and cardiac functions;
Exclusion Criteria:
- History of Interstitial Lung Disease (ILD).
- Drugs with known CYP2D6 inhibitory effects
- Drugs that are highly dependent on CYP2D6 for metabolism.
- Women who are pregnant or breastfeeding.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728468
Locations
| United States, New York | |
| Pfizer Investigational Site | |
| Amherst, New York, United States, 14221 | |
| Pfizer Investigational Site | |
| Buffalo, New York, United States, 14263 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Pfizer
Roswell Park Cancer Institute
South Texas Accelerated Research Therapeutics (START)
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00728468 History of Changes |
| Other Study ID Numbers: | A7471014 |
| Study First Received: | July 31, 2008 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 1 PF-00299804 Dextromethorphan CYP2D6 Inhibition Cancer Patients |
Additional relevant MeSH terms:
|
Neoplasms Dextromethorphan Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Antitussive Agents Central Nervous System Agents Therapeutic Uses Respiratory System Agents |
ClinicalTrials.gov processed this record on May 21, 2013