Phase 1
Completed N=36
Asian Phase I Study Of PF-03446962
Neoplasms
Source: ClinicalTrials.gov NCT01337050 ↗
Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Aug 2015
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — 10.0 mg/kg
Summary
This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose escalation and designed to define the Maximum Tolerated Dose [MTD] and the Recommended Phase 2 Dose [RP2D].
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
10.0 | — |
| PRIMARY Recommended Phase-2 Dose (RP2D) |
7.0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
3; 13; 19; 0; 1; 1 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity |
0; 4; 5; 1; 3; 6 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
3; 9; 14; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
2; 10; 13; 1; 1; 1 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
89420; 121100; 169000 | — |
| SECONDARY Minimum Observed Serum Trough Concentration (Cmin) |
6689; 14680; 22940 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
1.74; 2.00; 1.50 | — |
| SECONDARY Area Under the Curve From Time Zero to 28 Days [AUC (0-28)] |
12360000; 21980000; 30360000 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
12050000; 20500000; 26070000 | — |
| SECONDARY Systemic Clearance (CL) |
0.01880; 0.01482; NA | — |
| SECONDARY Volume of Distribution (Vd) |
7.535; 6.556; NA | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
14.58; 14.16; NA | — |
| SECONDARY Soluble Proteins Level |
NA; 5769662.5; 4529407.4; NA; 5013301.1; 4834240.9 | — |
| SECONDARY Number of Participants With Human Anti-Human Antibody (HAHA) |
0; 1; 3; 0; 0; 0 | — |
| SECONDARY Number of Participants With Best Overall Response (BOR) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinical Benefit Response (CBR) |
1; 4; 4 | — |
| SECONDARY Progression Free Survival (PFS) |
2.8; 1.8; 1.3 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of stomach cancer
- advanced/metastasis solid tumor refractory or intolerant to established therapy
- adequate blood chemistry, blood counts and kidney/liver function
- willing to participate to study requirements and sign an informed consent document
Exclusion Criteria
- Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication
- excessive toxicities related to prior therapies
- pregnant or breastfeeding patients
Data sourced from ClinicalTrials.gov (NCT01337050). 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. Informational only — not medical advice.