Trial Outcomes & Findings for A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients (NCT NCT00728468)
NCT ID: NCT00728468
Last Updated: 2017-08-02
Results Overview
Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Results posted on
2017-08-02
Participant Flow
Participant milestones
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
|
|---|---|
|
Overall Study
STARTED
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16
|
|
Overall Study
Treated
|
15
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
|
Overall Study
Enrolled but not treated
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Objective progression or relapse
|
9
|
|
Overall Study
Study terminated by sponsor
|
1
|
Baseline Characteristics
A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients
Baseline characteristics by cohort
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=15 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
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Age, Continuous
|
57.1 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Pharmacokinetic (PK) analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing
Dextromethorphan
|
206.4 nanograms*hour/milliliter (ng*hr/mL)
Standard Deviation 404.63
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing
Dextrorphan
|
2199 nanograms*hour/milliliter (ng*hr/mL)
Standard Deviation 1085.7
|
PRIMARY outcome
Timeframe: Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
|
|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7
Dextromethorphan
|
300.7 ng*hr/mL
Standard Deviation 408.42
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7
Dextrorphan
|
2232 ng*hr/mL
Standard Deviation 1253.2
|
PRIMARY outcome
Timeframe: Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
|
|---|---|
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan 3 Days Prior to PF-00299804 Dosing
|
2266 ng*hr/mL
Standard Deviation 955.97
|
PRIMARY outcome
Timeframe: Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan on Cycle 2 Day 7
|
2298 ng*hr/mL
Standard Deviation 1245.4
|
PRIMARY outcome
Timeframe: Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
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Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing
Dextromethorphan
|
6.598 ng/mL
Standard Deviation 7.4826
|
|
Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing
Dextrorphan
|
239.2 ng/mL
Standard Deviation 137.56
|
PRIMARY outcome
Timeframe: Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
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Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7
Dextromethorphan
|
11.11 ng/mL
Standard Deviation 7.8689
|
|
Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7
Dextrorphan
|
169.2 ng/mL
Standard Deviation 103.18
|
PRIMARY outcome
Timeframe: Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
|
|---|---|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing
Dextromethorphan
|
2.00 hours
Interval 1.03 to 6.0
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing
Dextrorphan
|
2.00 hours
Interval 2.0 to 6.0
|
PRIMARY outcome
Timeframe: Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7
Dextromethorphan
|
3.00 hours
Interval 2.0 to 6.08
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7
Dextrorphan
|
4.00 hours
Interval 2.0 to 4.0
|
PRIMARY outcome
Timeframe: Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
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Plasma Decay Half-Life (t1/2) For Dextrorphan 3 Days Prior to PF-00299804 Dosing
|
20.20 hours
Standard Deviation 28.645
|
PRIMARY outcome
Timeframe: Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
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Plasma Decay Half-Life (t1/2) For Dextrorphan on Cycle 2 Day 7
|
17.25 hours
Standard Deviation 15.935
|
PRIMARY outcome
Timeframe: Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 hours after dosing on Day -3Population: PK parameter analysis population: all participants enrolled who were extensive metabolizers (EM), \& treated who had at least 1 PK parameter of primary interest in at least 1 treatment period. EMs were defined as participants with a baseline UMR ≤0.3 \& were either ultrarapid, extensive, or intermediate metabolizers as predicted by CYP2D6 genotyping.
The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day -3 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day -3.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=4 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
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Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan 3 Days Prior to PF-00299804 Dosing
|
0.008800 ratio
Standard Deviation 0.017600
|
PRIMARY outcome
Timeframe: 8 hours after dosing on Day 7Population: PK parameter analysis population
The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day 7 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day 7.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=5 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
|
Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan on Cycle 2 Day 7
|
0.08040 ratio
Standard Deviation 0.11042
|
SECONDARY outcome
Timeframe: Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)Population: Response anslysis set: all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment.
BOR: investigator assessment by Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. Partial Response (PR): \>=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD): \>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \>=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=7 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
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|---|---|
|
Best Overall Response (BOR)
Complete response
|
0 participants
|
|
Best Overall Response (BOR)
Partial response
|
1 participants
|
|
Best Overall Response (BOR)
Stable/No response
|
1 participants
|
|
Best Overall Response (BOR)
Objective progression
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)Population: Participants with a response (CR or PR) in response analysis set.
Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=1 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
|
|---|---|
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Duration of Response (DR)
|
NA weeks
One participant achieved partial response as best overall response on Day 42 and remained as partial response for the duration of the study. Therefore, data were not calculable.
|
SECONDARY outcome
Timeframe: Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)Population: All enrolled participants
Time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.437. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD).
Outcome measures
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=16 Participants
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
|
|---|---|
|
Time to Tumor Progression (TTP)
|
1.4 months
Interval 1.3 to
Not calculable.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator's decision.
Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator's decision.
Dextrorphan is an active metabolite of dextromethorphan.
Outcome measures
Outcome data not reported
Adverse Events
PF-00299804 45 mg + Dextromethorphan 30 mg
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=15 participants at risk
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
|
|---|---|
|
Gastrointestinal disorders
Colonic obstruction
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Vomiting
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
PF-00299804 45 mg + Dextromethorphan 30 mg
n=15 participants at risk
PF-00299804 45 milligram (mg) tablet orally once daily, starting from Cycle 1 Day 1, continuously for 21-day cycles until disease progression or unacceptable toxicities along with single dose of dextromethorphan hydrobromide 30 mg orally 3 days prior to Cycle 1 Day 1 (Day -3) and on Day 7 of Cycle 2.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Deafness
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear disorder
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Cheilitis
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
53.3%
8/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oral pain
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Early satiety
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
20.0%
3/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Mucosal inflammation
|
33.3%
5/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Conjunctivitis
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Localised infection
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
20.0%
3/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
46.7%
7/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborroeic keratosis
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysarthria
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
5/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
5/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
46.7%
7/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
3/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
13.3%
2/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
20.0%
3/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Adverse events were recorded from the time that the participant provided informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER