Trial · NCT00940498
Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors
NCT00940498, Phase 1, Completed, Pfizer; results first posted 2018-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors. Trials, record NCT00940498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00940498
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors
- NCT number
- NCT00940498
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 78 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Neoplasms
- Interventions
- PF-05212384 (also known as PKI-587)
- First posted
- 2009-07-16
- Last updated
- 2018-11-02
- Other registries' IDs
- eudract:2009-012379-85
- Results first posted
- 2018-11-02
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Cycle 14 (each cycle is 28 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Cycle 14, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. |
| Primary | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Cycle 14 (each cycle is 28 days) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Cycle 14, that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs included both serious and non-serious adverse events. |
| Primary | Number of Participants With Laboratory Abnormalities | Baseline up to Cycle 14 (each cycle is 28 days) | Criteria for laboratory test abnormality: hematology (hemoglobin \[less than {\<} 0.8\*lower limit of normal {LLN}\], platelets \[\<0.5\*LLN or greater than {\>} 1.75\*upper limit of normal {ULN}\], white blood cells \[\<0.6\*LLN or \>1.5\*ULN\], lymphocytes \[\<0.8\*LLN or \>1.2\*ULN\], total neutrophils \[\<0.8\*LLN or \>1.2\*ULN\], basophils, eosinophils, monocytes \[\>1.2\*ULN\]); coagulation \[partial thromboplastin time, prothrombin (PT), PT international ratio \[\>1.1\*ULN\]); liver function (total bilirubin \[\>1.5\*ULN\], aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase \[\>0.3\*ULN\], total protein, albumin \[\<0.8\*LLN or \>1.2\*ULN\]). |
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | Baseline up to Day 28 | DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: Grade 3 nonhematologic AE (including nausea, vomiting, or diarrhea despite optimal therapy; or greater than or equal to \[\>=\] grade 3 asthenia \>2 days; or fasting serum glucose \>250 milligrams per deciliter (mg/dL) despite optimal therapy); \>=Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade 4 neutropenia lasting more than 7 days; Febrile neutropenia; other Grade 4 hematologic AE; delay of treatment \>2 consecutive weeks due to toxicity. Grades were based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. |
| Primary | Recommended Phase-2 Dose (RP2D) | Baseline up to Cycle 14 (each cycle is 28 days) | RP2D of PF-05212384 was determined based on the safety profile including laboratory and clinical assessments and pharmacodynamics findings. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-05212384: Single and Multiple Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1; Cycle 2: predose, 0.5, 24, 72, 120 hours postdose on Day 1 | |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05212384: Single Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1 | Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (Clast). |
| Secondary | Plasma Decay Half-Life (t1/2) of PF-05212384: Single and Multiple Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1; Cycle 2: predose, 0.5, 24, 72, 120 hours postdose on Day 1 | Plasma decay half-life is the time measured for the plasma concentration of drug to decrease by one half. |
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-05212384: Single Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1 | AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - inf). |
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05212384: Single and Multiple Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1; Cycle 2: predose, 0.5, 24, 72, 120 hours postdose on Day 1 | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 168 hours (1 Week). For Cycle 2, the last PK sample for parameter calculations was on 120 hours after the Day 1 dose, however AUCtau was extrapolated to 168 hours using t1/2. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Cycle 14 (each cycle is 28 days) | Safety analysis set included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to Cycle 14 (each cycle is 28 days) | Safety analysis set included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities | Baseline up to Cycle 14 (each cycle is 28 days) | Safety analysis set included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) | Baseline up to Day 28 | DLT evaluable analysis set included all enrolled participants who started treatment and did not have had a major treatment deviation in the first cycle of treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Recommended Phase-2 Dose (RP2D) | Baseline up to Cycle 14 (each cycle is 28 days) | Safety analysis population included all participants who received at least 1 dose of study medication. | mg | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of PF-05212384: Single and Multiple Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1; Cycle 2: predose, 0.5, 24, 72, 120 hours postdose on Day 1 | PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05212384: Single Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1 | PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | nanogram*hour per milliliter(ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Plasma Decay Half-Life (t1/2) of PF-05212384: Single and Multiple Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1; Cycle 2: predose, 0.5, 24, 72, 120 hours postdose on Day 1 | PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated. | hours (hr) | MEAN |
| SECONDARY | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-05212384: Single Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1 | PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05212384: Single and Multiple Dose | Cycle 1: predose, 0.5, 2, 3, 6, 24, 72, 120 and 168 hours postdose on Day 1; Cycle 2: predose, 0.5, 24, 72, 120 hours postdose on Day 1 | PK parameter analysis population included all enrolled participants who received at least 1 dose of study drug and had at least 1 of the PK parameters of interest estimated. | ng*hr/mL | GEOMETRIC_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group411
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1: PF-05212384 10 mg | AEs | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1: PF-05212384 21 mg | AEs | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1: PF-05212384 43 mg | AEs | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1: PF-05212384 89 mg | AEs | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1 and 2: PF-05212384 154 mg | AEs | 42 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1: PF-05212384 222 mg | AEs | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1: PF-05212384 266 mg | AEs | 8 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1: PF-05212384 319 mg | AEs | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1: PF-05212384 10 mg | SAEs | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Part 1: PF-05212384 21 mg | SAEs | 1 | Participants |
1 to 10 of 411Source ClinicalTrials.gov
See all 411 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: PF-05212384 10 mg | 4 | |
| Overall Study | STARTED | Part 1: PF-05212384 21 mg | 4 | |
| Overall Study | STARTED | Part 1: PF-05212384 43 mg | 4 | |
| Overall Study | STARTED | Part 1: PF-05212384 89 mg | 4 | |
| Overall Study | STARTED | Part 1 and 2: PF-05212384 154 mg | 43 | |
| Overall Study | STARTED | Part 1: PF-05212384 222 mg | 7 | |
| Overall Study | STARTED | Part 1: PF-05212384 266 mg | 8 | |
| Overall Study | STARTED | Part 1: PF-05212384 319 mg | 4 | |
| Overall Study | COMPLETED | Part 1: PF-05212384 10 mg | 1 | |
| Overall Study | COMPLETED | Part 1: PF-05212384 21 mg | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events2,472
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 | Part 1: PF-05212384 10 mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: PF-05212384 21 mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: PF-05212384 43 mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: PF-05212384 89 mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 and 2: PF-05212384 154 mg | 6 | 42 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: PF-05212384 222 mg | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: PF-05212384 266 mg | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: PF-05212384 319 mg | 2 | 4 | |
| other | Hypochromic anaemia | Blood and lymphatic system disorders | Part 1: PF-05212384 10 mg | 0 | 4 | |
| other | Hypochromic anaemia | Blood and lymphatic system disorders | Part 1: PF-05212384 21 mg | 0 | 4 |
1 to 10 of 2,472Source ClinicalTrials.gov
See all 2,472 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: PF-05212384 10 mg | ||
| Total, all-cause mortality | Part 1: PF-05212384 21 mg | ||
| Total, all-cause mortality | Part 1: PF-05212384 43 mg | ||
| Total, all-cause mortality | Part 1: PF-05212384 89 mg | ||
| Total, all-cause mortality | Part 1 and 2: PF-05212384 154 mg | ||
| Total, all-cause mortality | Part 1: PF-05212384 222 mg | ||
| Total, all-cause mortality | Part 1: PF-05212384 266 mg | ||
| Total, all-cause mortality | Part 1: PF-05212384 319 mg | ||
| Total, other adverse events | Part 1: PF-05212384 10 mg | 4 | 4 |
| Total, other adverse events | Part 1: PF-05212384 21 mg | 4 | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25652454 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00940498
GET https://conductscience.org/api/trials/v1/NCT00940498/results?page=2