NCT00434174
Completed
Phase 1
A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy
Overview
- Phase
- Phase 1
- Intervention
- Everolimus
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
everolimus + Pemetrexed - daily
Daily treatment
Intervention: Everolimus
everolimus + Pemetrexed - daily
Daily treatment
Intervention: Pemetrexed
everolimus + Pemetrexed - weekly
Weekly treatment
Intervention: Everolimus
everolimus + Pemetrexed - weekly
Weekly treatment
Intervention: Pemetrexed
Outcomes
Primary Outcomes
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
Time Frame: Over 18 weeks of combination treatment
Secondary Outcomes
- Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)(Over 18 weeks of combination treatment)
Study Sites (1)
Loading locations...
Similar Trials
Terminated
Phase 1
Everolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin LymphomaRecurrent Hodgkin LymphomaRefractory Hodgkin LymphomaNCT02254239Mayo Clinic10
Active, not recruiting
Phase 2
Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial CancerAdvanced, Persistent, or Recurrent Endometrial CancerNCT02228681GOG Foundation74
Recruiting
Phase 2
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast CancerBreast CancerAdvanced Breast CancerNCT05949541Fudan University265
Unknown
Phase 2
Single Arm Trial With Combination of Everolimus and Letrozole in Treatment of Platinum Resistant Relapse or Refractory or Persistent Ovarian Cancer/Endometrial CancerOvarian CancerEndometrial CancerNCT02188550Sinai Hospital of Baltimore20
Terminated
Phase 1
Phase I Trial of Everolimus, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple MyelomaMultiple Myeloma in RelapseNCT01889420New Mexico Cancer Care Alliance1