Lung Cancer Clinical Trial
Official title:
A Phase Ib, Open-Label, Sequential, Dose-Finding, Study of AMG 706 in Combination With Gemcitabine to Treat Subjects With Solid Tumors
RATIONALE: AMG 706 may stop the growth of cancer cells by blocking blood flow to the cancer
or by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such
as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Giving AMG 706 together with gemcitabine may
kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of AMG 706 when given
together with gemcitabine in treating patients with advanced solid tumors or lymphoma.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and safety of AMG 706 when given in combination
with gemcitabine hydrochloride in patients with advanced solid tumors or lymphoma.
Secondary
- Determine the pharmacokinetic profiles of this regimen in these patients.
OUTLINE: This is a multicenter, open-label, dose-escalation study of AMG 706.
Patients receive oral AMG 706 once daily on days 2-56 and gemcitabine hydrochloride IV over
30 minutes on days 1, 8, 15, 22, 29, 36, and 43 of course 1. For all subsequent courses,
patients receive oral AMG 706 on days 1-28 and gemcitabine hydrochloride IV over 30 minutes
on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 10 courses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of AMG 706 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients
experience dose-limiting toxicity.
During the first course of study treatment, patients undergo blood collection periodically
for pharmacokinetic analysis.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
| Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
| Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
| Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
| Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
| Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
| Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
| Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
| Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
| Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
| Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|