Clinical trial · Interventional
A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors
A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Anti-A5B1 Integrin Monoclonal Antibody PF-04605412 Administered Intravenously To Adult Patients With Advanced Or Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated on 26 February 2013. Risk-benefit assessment is no longer positive and does not support further development
Summary
Brief summary (as posted)
Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-Hematologic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-04605412 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PF-04605412
- interventionNames
- Drug: PF-04605412
Primary outcomes (1)
- measure
- Number of Participants With Dose-limiting Toxicities (DLT)
- timeFrame
- Baseline up to 6 weeks PF-04605412
- description
- 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: any grade 3 or 4 clinically-relevant non-hematologic toxicity,any \>= Grade 3 adverse event (AE) graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0 without a clear alternative explanation to study treatment relationship occurring during the first 6 weeks of treatment with PF-04605412. DLT was used to determine maximum tolerated dose (MTD) in this study.
Secondary outcomes (22)
- measure
- Maximum Observed Serum Concentration (Cmax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1 * Life expectancy more than12 weeks * Adequate bone marrow, liver and renal function Exclusion Criteria: * Known brain metastasis * Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of start of screening procedures * Major surgical procedure within 4 weeks of start of screening procedures * Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months
References
Publications (0)
Data not yet available