Clinical trial · Interventional
A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin
An Open-Label, Non-controlled, Non-randomized Sequential Design, Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin in Patients With Advanced Solid Cancers
NCT01606748CI-TRIAL-00040915completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the pharmacokinetics (PK) of necitumumab in combination with gemcitabine-cisplatin in participants with advanced malignant solid tumors and to assess the potential for drug-drug interactions between necitumumab and gemcitabine-cisplatin.
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 |
|---|---|---|---|
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Necitumumab | Biological | Necitumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Necitumumab, Gemcitabine and Cisplatin
- description
- The study will be conducted in two sequential periods: a 3-week PK run-in participants will be treated sequentially with single doses of cisplatin, gemcitabine, and necitumumab. Cycle 1 will begin immediately following the PK run-in period.
- interventionNames
- Biological: Necitumumab
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (8)
- measure
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab
- timeFrame
- Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion
- measure
- PK: Dose-Normalized Cmax of Gemcitabine
- timeFrame
- Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have documented advanced or metastatic malignant solid tumors (except for colorectal tumors with KRAS mutation) that are resistant to standard therapy or for which no standard therapy is available * May have measurable or non-measurable disease * Have resolution to Grade 0 or 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE 4.0) of all clinically significant toxic effects (other than alopecia) of prior chemotherapy, surgery, radiotherapy, or hormonal therapy * Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 * Have adequate hepatic, hematologic and renal function * If female, are surgically sterile, postmenopausal, or agree to be compliant with a highly effective contraceptive method during and for 6 months after the treatment period. If male, are surgically sterile or agree to be compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period * Female participants of childbearing potential have a negative serum pregnancy test within 7 days prior to the first dose of study therapy Exclusion Criteria: * Have received a systemic anticancer agent (including EGFR tyrosine kinase inhibitors) or device within 28 days prior to first dose of study therapy * The most recent anticancer therapy received by the participant included either gemcitabine or cisplatin (or both) * Have received radiotherapy within 14 days prior to first dose of study therapy * Have received cytotoxic chemotherapy within 21 days prior to first dose of study therapy * Are receiving concurrent treatment with another anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiation therapy, chemoembolization, or targeted therapy * Are considered surgical candidates (with resectable disease) * Have brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants * Have narrowing of or blockage in large veins * Have coronary artery disease or uncontrolled congestive heart failure * Have uncontrolled angina pectoris, or experienced myocardial infarction within 6 months prior to first dose of study therapy * Have an ongoing or active infection (requiring treatment), including active tuberculosis or known infection with the human immunodeficiency virus * Have a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder * Have known drug or alcohol abuse * If female, are pregnant or breastfeeding * Have had major surgery within 28 days prior to first dose of study medication or subcutaneous venous access device implantation within 7 days prior to first dose of study therapy * Are currently enrolled in, or discontinued within the 30 days prior to first dose of study therapy from a clinical trial involving an investigational product or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
References
Publications (0)
Data not yet available
No reference posted for this study.