Clinical trial · Interventional
Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
NCT00729833CI-TRIAL-00014800terminatedPhase 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)
The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.
Conditions
Conditions (2)
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-751,871 | Drug | — | UNRESOLVED |
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CP-751,871 + Sunitinib
- description
- Escalating cohorts of CP-751,871 + Sunitinib
- interventionNames
- Drug: CP-751,871
- Drug: Sunitinib
Primary outcomes (1)
- measure
- Number of Participants With Dose-Limiting Toxicities (DLT)
- timeFrame
- Baseline up to the end of Cycle 1 (each cycle=3 weeks)
- description
- Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (\>=) 7 days delay in administration of Cycle 2. Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Secondary outcomes (14)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists. * ECOG Performance Status of 0 or 1; * Total IGF-1 level ≥100 ng/ml; * ECOG Performance Status of 0 or 1 * Adequate bone marrow, renal, and hepatic function Exclusion Criteria: * Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients * Treatment with any other investigational therapy within 4 weeks prior to study treatment * Major surgery within 4 weeks of study treatment * Prior treatment that may increase the risk of cardiac complications * Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater * Significant active cardiac disease, including hypertension that cannot be controlled by medications * Greater than three (3) prior lines of cytotoxic therapy; * Active infection * Prior IGF-IR targeted therapy;
References
Publications (0)
Data not yet available
No reference posted for this study.