Non Small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer
This is a study of the drug perifosine that consists of 2 parts. The first part of this study
was designed to determine the highest dose of perifosine that can be administered to people
every week without severe or prolonged nausea, vomiting and diarrhea. This study started with
patients taking 900 mg/week and went up to 1800 mg/week. Part I of this study is completed.
The MTD had been determined and incorporated in Part II.
The goals in Part II are to:
1. Compare the gastrointestinal toxicity of 3 different dose-schedules and
2. Obtain preliminary information on the response rate of perifosine in non-small cell lung
cancer.
The primary purpose of Part I of this study was to determine the maximum dose of perifosine
that can be administered with tolerable gastrointestinal toxicity; and to obtain preliminary
information on the response rate of perifosine in non-small cell lung cancer. In addition,
the trial was and is designed to provide some insight into the nature of the anti-tumor
effect, the time to response, and dose-schedules that should be used in future trials.
Part 2 - In the second part of this study, patients will be randomized to one of 3
dose-schedules of perifosine and to test if the response rate of perifosine in non small cell
lung cancer is > 10% in any of the 3 arms of the study. The study is not designed to compare
the response rates in the 3 arms of the trial, but toxicities will be compared. The regimens
are:
- A weekly dose of 900 mg to be divided into three doses of 300 mg each. If patients
experience no grade 2 toxicities during their first month of therapy, the dose will be
escalated to 1,200 mg divided into four doses of 300 mg.
- A daily dose of 150 mg to be divided into three doses of 50 mg each. If patients
experience no grade 2 toxicities during their first month of therapy, the dose will be
escalated to 200 mg divided into four doses of 50 mg.
- A daily dose of 150 mg to be given in one dose at bedtime. If patients experience no
grade 2 toxicities during their first month of therapy, the dose will be escalated to
200 mg to be given in one dose at bedtime.
Patients receiving weekly perifosine will receive prophylactic antiemetics. Patients
receiving daily perifosine will not routinely receive prophylactic antiemetics unless they
experience nausea. All patients may continue therapy unless disease progression is documented
on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on
treatment with doses delayed or reduced.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
| Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
| Completed |
NCT01945021 -
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
|
Phase 2 | |
| Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
| Terminated |
NCT04022876 -
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
|
Phase 1 | |
| Recruiting |
NCT05898763 -
TEIPP Immunotherapy in Patients With NSCLC
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05532696 -
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
|
Phase 1/Phase 2 | |
| Completed |
NCT04311034 -
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
| Terminated |
NCT03257722 -
Pembrolizumab + Idelalisib for Lung Cancer Study
|
Phase 1/Phase 2 | |
| Completed |
NCT00349089 -
Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy
|
Phase 2 | |
| Completed |
NCT05116891 -
A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04571632 -
Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors
|
Phase 2 | |
| Terminated |
NCT03599518 -
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT06020989 -
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
|
Phase 2 | |
| Withdrawn |
NCT03982134 -
PDR001 + Panobinostat for Melanoma and NSCLC
|
Phase 1 | |
| Withdrawn |
NCT03574649 -
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
|
Phase 2 | |
| Withdrawn |
NCT02844140 -
DE-CT in Lung Cancer Proton Therapy
|
N/A | |
| Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 |