Phase 1
N=23
A Study Of PF-04449913 Administered Alone In Select Solid Tumors
Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT01286467 ↗Enrolled (actual)
23
Serious AEs
43.5%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) — 0; 0; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-04449913 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) |
0; 0; 0; 2 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade |
0.0; 0.0; 14.3; 0.0; 50.0; 50.0 | — |
| SECONDARY Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade |
50.0; 25.0; 42.9; 0.0; 25.0; 50.0 | — |
| SECONDARY Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression (Ratio) to Baseline for Normal Skin on Cycle 1/Day 15 |
0.1; 0.1; 0.1; 0.1 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 1 |
1161; 1126; 2624; 6299 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 25 |
1373; 1567; 3363; 4913 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 1 |
1.5; 2; 2.1; 2 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 25 |
1; 2; 2; 4 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 1 |
10510; 12540; 31160; 62550 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 25 |
13930; 18670; 46670; 70600 | — |
| SECONDARY Plasma Decay Half-life (t1/2) on Cycle 1/Day 25 |
19; 21; 21; 18 | — |
| SECONDARY Apparent Oral Clearance (CL/F) on Cycle 1/Day 25 |
7.2; 9.1; 8.0; 9.6 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) on Cycle 1/Day 25 |
182; 286; 234; 249 | — |
| SECONDARY Accumulation Ratio (Rac) on Cycle 1/Day 25 |
1.4; 2.2; 1.7; 1.6 | — |
| SECONDARY Average Concentration at Steady State (Cavg) on Cycle 1/Day 25 |
580; 777; 1942; 2943 | — |
| SECONDARY Number of Participants With Increase From Baseline in Corrected QT Using Fridericia's Formula (QTcF) Interval |
3; 4; 4; 2; 1; 0 | — |
| SECONDARY Number of Participants With Decrease From Baseline in QTcF Interval |
4; 4; 6; 4; 0; 0 | — |
| SECONDARY Number of Participants With Post-baseline QTcF Interval Greater Than or Equal to 500 Msec |
0; 0; 1; 0 | — |
| SECONDARY Percentage of Participants With Objective Response |
0; 0; 0; 0 | — |
| SECONDARY Progression-Free Survival (PFS) |
— | — |
| SECONDARY Time to Progression (TTP) |
— | — |
| SECONDARY Duration of Response (DR) |
— | — |
Summary
This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.
Eligibility Criteria
Inclusion Criteria
- Histological or cytological diagnosis of advanced/metastatic solid tumor
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
Exclusion Criteria
- Patients with known symptomatic brain metastases requiring steroids
- Current active treatment on another clinical trial
- Major surgery or radiation therapy within 4-weeks of starting study treatment
Data sourced from ClinicalTrials.gov (NCT01286467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.