Trial · NCT00818441
Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
NCT00818441, Phase 2, Completed, Pfizer; results first posted 2016-06-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung. Trials, record NCT00818441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00818441
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung
- NCT number
- NCT00818441
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 119 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Non-small Cell
- Interventions
- Dacomitinib (PF-00299804), Dacomitinib (PF-00299804)
- First posted
- 2009-01-07
- Last updated
- 2019-01-08
- Other registries' IDs
- eudract:2011-002794-39
- Results first posted
- 2016-06-01
- Limitations and caveats
- Results have been included for Cohort B and updated for Cohort A since the Primary completion date.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) at Month 4: Cohort A | Baseline up to Month 4 | PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease \[PD\] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (\>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions. |
| Secondary | Progression-Free Survival (PFS) at Month 4: Cohort B | Baseline up to Month 4 | PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as PD or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on RECIST v1.0 criteria. PD: \>=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions. |
| Secondary | Progression-Free Survival (PFS) | Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. | PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date \[if not reached, censored date as the last known event-free date\] minus first dosing date plus 1) divided by 30.44. PD: \>= 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions. Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria. |
| Secondary | Best Overall Response (BOR) | Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. | BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0. Complete Response (CR): disappearance of all lesions. Partial Response (PR): \>=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions. PD: \>=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of \>=1 new lesion, or unequivocal progression in non-target lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. CR and PR had to be confirmed on a follow up imaging assessment \>=4 weeks after the initial objective documentation of the response. SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks. |
| Secondary | Duration of Response (DR) | Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. | Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause \[if not reached, censored date\] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for a subgroup of participants with a confirmed objective tumor response. |
| Secondary | Overall Survival (OS) | Randomization until death or last date known to be alive. | Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
| Secondary | European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score | Baseline (Cycle [C]1 Day 1), up to C75 | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms. Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales. Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales. Stable was a mean change from baseline of \<10. |
| Secondary | European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score | Baseline (C1D1) up to C75 | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ). Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain. Improvement was defined as a mean decrease from baseline of ≤10. Worsened was defined as a mean increase from baseline of ≥10. Stable was a mean change from baseline of \<10. |
| Secondary | Trough Plasma Concentrations (Ctrough) of Dacomitinib | Predose on C1D14, C2D1, C3D1, C4D1 | Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) at Month 4: Cohort A | Baseline up to Month 4 | As-enrolled population included all participants who were enrolled in the study. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) at Month 4: Cohort B | Baseline up to Month 4 | percent chance of being event-free | NUMBER | |
| SECONDARY | Progression-Free Survival (PFS) | Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. | As-enrolled population included all participants who were enrolled in the study. | months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) | Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. | Response-evaluable population included all enrolled participants who received at least 1 dose of study medication, had an adequate baseline tumor assessment, and had at least 1 on-study tumor assessment after the first dosing. | participants | NUMBER |
| SECONDARY | Duration of Response (DR) | Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. | DR was calculated for a subgroup of participants from the response-evaluable population, who had confirmed objective tumor response (CR or PR). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization until death or last date known to be alive. | As-enrolled population included all participants who were enrolled in the study. | months | MEDIAN |
| SECONDARY | European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score | Baseline (Cycle [C]1 Day 1), up to C75 | Patient reported Outcome (PRO) analysis set:participants who received at least (\>=) 1 dose of study medication (as-treated population), had baseline PRO assessments, \>=1 on-study assessment submitted. 'N' (number of participants analyzed)=participants evaluable for this measure.n=participants evaluable at specified time points for given parameter. | number of participants | NUMBER |
| SECONDARY | European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score | Baseline (C1D1) up to C75 | PRO analysis set: participants who received \>=1 dose of study medication (as-treated population), had baseline PRO assessments, \>=1 on-study assessment submitted. n=participants evaluable at specified time points for given parameter. | number of participants | NUMBER |
| SECONDARY | Trough Plasma Concentrations (Ctrough) of Dacomitinib | Predose on C1D14, C2D1, C3D1, C4D1 | Pharmacokinetic (PK) analysis set: all participants who received at least 1 dose of study medication at selected PK sites from whom at least 1 PK sample were obtained. 'N' (number of participants analyzed) = participants who were evaluable for this measure at any time point. n = participants evaluable at given time points for specified dose. | nanogram per milliliter (ng/mL) | MEAN |
Source ClinicalTrials.gov
Results by group200
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) at Month 4: Cohort A | Dacomitinib: Cohort A | 76.9 | 95% Confidence Interval 66.4 to 84.4 | percentage of participants | |
| Progression-Free Survival (PFS) at Month 4: Cohort B | Dacomitinib: Cohort B | 24.9 | 95% Confidence Interval 11.0 to 41.7 | percent chance of being event-free | |
| Progression-Free Survival (PFS) | Dacomitinib: Cohort A | 11.5 | 95% Confidence Interval 9.0 to 12.9 | months | |
| Progression-Free Survival (PFS) | Dacomitinib: Cohort B | 2.6 | 95% Confidence Interval 1.8 to 3.7 | months | |
| Best Overall Response (BOR) | Dacomitinib: Cohort A | Complete Response | 1 | participants | |
| Best Overall Response (BOR) | Dacomitinib: Cohort B | Complete Response | 0 | participants | |
| Best Overall Response (BOR) | Dacomitinib: Cohort A | Partial Response | 47 | participants | |
| Best Overall Response (BOR) | Dacomitinib: Cohort B | Partial Response | 3 | participants | |
| Best Overall Response (BOR) | Dacomitinib: Cohort A | Stable Disease | 27 | participants | |
| Best Overall Response (BOR) | Dacomitinib: Cohort B | Stable Disease | 11 | participants |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dacomitinib: Cohort A | 89 | |
| Overall Study | STARTED | Dacomitinib: Cohort B | 30 | |
| Overall Study | COMPLETED | Dacomitinib: Cohort A | 0 | |
| Overall Study | COMPLETED | Dacomitinib: Cohort B | 0 | |
| Overall Study | NOT COMPLETED | Dacomitinib: Cohort A | 89 | |
| Overall Study | NOT COMPLETED | Dacomitinib: Cohort B | 30 |
Source ClinicalTrials.gov
Adverse events822
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dacomitinib: Cohort A | 5 | 89 | |
| other | Anaemia | Blood and lymphatic system disorders | Dacomitinib: Cohort B | 0 | 30 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dacomitinib: Cohort A | 1 | 89 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Dacomitinib: Cohort B | 0 | 30 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Dacomitinib: Cohort A | 1 | 89 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Dacomitinib: Cohort B | 0 | 30 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dacomitinib: Cohort A | 1 | 89 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dacomitinib: Cohort B | 0 | 30 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Dacomitinib: Cohort A | 2 | 89 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Dacomitinib: Cohort B | 0 | 30 |
1 to 10 of 822Source ClinicalTrials.gov
See all 822 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dacomitinib: Cohort A | ||
| Total, all-cause mortality | Dacomitinib: Cohort B | ||
| Total, other adverse events | Dacomitinib: Cohort A | 89 | 89 |
| Total, other adverse events | Dacomitinib: Cohort B | 30 | 30 |
| Total, serious adverse events | Dacomitinib: Cohort A | 29 | 89 |
| Total, serious adverse events | Dacomitinib: Cohort B | 9 | 30 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dacomitinib: Cohort A vs Dacomitinib: Cohort B: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00818441
GET https://conductscience.org/api/trials/v1/NCT00818441/results?page=2