A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
Trial · NCT00557856
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD): Part 1 | Baseline up to 42 days after the start of each increased treatment dose | The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug. | milligram/kilogram (mg/kg) | NUMBER |
| PRIMARY | Recommended Phase 2 Dose (RP2D): Part 1 | Baseline up to 42 days after the start of each increased treatment dose | The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug. | mg/kg | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Safety population included all enrolled participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Safety population included all enrolled participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Safety population included all enrolled participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Data for timing was reported in individual participant listing for every adverse event (AE) and mentioned for description of narrative of Serious AEs but was not statistically summarized for analysis on the entire safety population, as planned. | ||
| SECONDARY | Number of Participants With Laboratory Abnormalities: Part 1 and Part 2 | Cycle 1 of Day 1 up to 28 days after the last dose of treatment | Safety population included all enrolled participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response: Part 1 and Part 2 | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 | Response-evaluable set included all participants who received at least 1 dose of study drug with an adequate baseline tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control: Part 2 | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 | Response-evaluable set included all participants who started Cycle 1 with an adequate baseline tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Time To Progression (TTP): Part 2 | Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490 | Safety population included all participants who received at least one dose of study drug. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2 | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2 | 0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12 | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here N (Number of participants analyzed) signifies those who were evaluable for the measure and n signifies those participants who were evaluable at specific time-point. | ng/mL | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2 | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here N (Number of participants analyzed) signifies those who were evaluable for the measure. | hour | MEDIAN |
| OTHER_PRE_SPECIFIED | Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2 | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here N (Number of participants analyzed) signifies those who were evaluable for the measure. | nanogram*hour/milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2 | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here N (Number of participants analyzed) signifies those who were evaluable for the measure. | ng*hr/mL | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Systemic Clearance(CL): Part 1 and Part 2 | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here N (Number of participants analyzed) signifies those who were evaluable for the measure. | liter/hour (L/hr) | GEOMETRIC_MEAN |
| SECONDARY | Volume of Distribution: Part 1 and Part 2 | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here N (Number of participants analyzed) signifies those who were evaluable for the measure. | liter (L) | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Plasma Decay Half-Life (t1/2): Part 1 and Part 2 | 0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms) | Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here N (Number of participants analyzed) signifies those who were evaluable for the measure. | hours | MEAN |
| OTHER_PRE_SPECIFIED | Human Anti - Human Antibody (HAHA) Concentration: Part 1 and Part 2 | Baseline up to 3 months after last dose | Statistical Data was not statistically summarized as majority of participants had concentration below the limit of quantification. | ||
| OTHER_PRE_SPECIFIED | Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2 | Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490) | Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. n signifies those participants who were evaluable at specific time-point. | picogram/milliliter (pg/mL) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00557856/outcomes