Phase 1
N=16
A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients
Advanced Malignant Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00728468 ↗Enrolled (actual)
16
Serious AEs
20.0%
Results posted
Aug 2017
Primary outcome: Primary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing — 206.4; 2199 nanograms*hour/milliliter (ng*hr/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-00299804 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing |
206.4; 2199 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7 |
300.7; 2232 | — |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan 3 Days Prior to PF-00299804 Dosing |
2266 | — |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan on Cycle 2 Day 7 |
2298 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing |
6.598; 239.2 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7 |
11.11; 169.2 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing |
2.00; 2.00 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7 |
3.00; 4.00 | — |
| PRIMARY Plasma Decay Half-Life (t1/2) For Dextrorphan 3 Days Prior to PF-00299804 Dosing |
20.20 | — |
| PRIMARY Plasma Decay Half-Life (t1/2) For Dextrorphan on Cycle 2 Day 7 |
17.25 | — |
| PRIMARY Oral Clearance For Dextromethorphan 3 Days Prior to PF-00299804 Dosing |
— | — |
| PRIMARY Oral Clearance For Dextromethorphan on Cycle 2 Day 7 |
— | — |
| PRIMARY Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan 3 Days Prior to PF-00299804 Dosing |
0.008800 | — |
| PRIMARY Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan on Cycle 2 Day 7 |
0.08040 | — |
| SECONDARY Best Overall Response (BOR) |
0; 1; 1; 5 | — |
| SECONDARY Duration of Response (DR) |
NA | — |
| SECONDARY Time to Tumor Progression (TTP) |
1.4 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00728468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.