Clinical trial · Interventional
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors
NCT00976508CI-TRIAL-00012976terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See termination reason in detailed description.
Summary
Brief summary (as posted)
This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| figitumumab | Drug | — | UNRESOLVED |
| pegvisomant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: figitumumab
- Drug: pegvisomant
Primary outcomes (2)
- measure
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- From Screening to the follow-up visit (90 days after last dose of figitimumab)
- description
- Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade \[Gr\] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
- measure
- Number of Participants With Dose Limiting Toxicities (DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥18 years of age with advanced solid tumors for which the combination of figitumumab and pegvisomant are reasonable treatment options. * Patients between the ages of 10 and 18 years with advanced sarcomas for which there is no available curative therapy or therapy proven to prolong survival with an acceptable quality of life will be included in the Sarcoma Expansion Cohort. * Adequate recovery from prior therapies. * Adequate organ function (i.e. bone marrow, kidney, liver) * Total IGF-1 ≥100 ng/ml (13 nmol/L). Exclusion Criteria: * Concurrent treatment with any anti-tumor agents. * Pregnant or breastfeeding females. * Significant past history or active cardiac disease * Active infection * History of diabetes mellitus. * Glycosylated hemoglobin \>5.7
References
Publications (0)
Data not yet available
No reference posted for this study.