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Protease Inhibitor
Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma
Phase 2
Waitlist Available
Led By Soren Gantt
Research Sponsored by AIDS Malignancy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how well nelfinavir mesylate works in treating patients with kaposi sarcoma.
Eligible Conditions
- Kaposi Sarcoma
- Kaposi's Sarcoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Negative Participants
Efficacy of Therapeutic Escalation of Standard Dose Nelfinavir, Followed by High Dose Nelfinavir, for Treatment of Kaposi Sarcoma Lesions for HIV Positive Participants
Secondary study objectives
Assess the Effect of Nelfinavir on KSHV Copy Number in Saliva
Assess the Effect of Nelfinavir on KSHV Gene Expression in Tumor Tissue
Correlate Nelfinavir and the Primary Active Metabolite, M8, Concentrations With Tumor Response, Antiviral Response, and Adverse Effects in Participants With KS.
+2 moreOther study objectives
Effect of Nelfinavir on CMV Copy Number in Saliva
Effect of Nelfinavir on EBV Copy Number in Saliva
Effect of Nelfinavir on HSV Copy Number in Saliva
+1 moreSide effects data
From 2023 Phase 2 trial • 36 Patients • NCT0307745177%
DIARRHEA
26%
NAUSEA
23%
HYPERTRIGLYCERIDEMIA
19%
HYPERTENSION
19%
Anemia
16%
COUGH
16%
SORE THROAT
13%
PAIN
13%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
13%
HYPERGLYCEMIA
13%
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
13%
DIZZINESS
13%
PAIN IN EXTREMITY
13%
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
13%
HEADACHE
10%
ABDOMINAL PAIN
10%
INSOMNIA
10%
NASAL CONGESTION
10%
EDEMA LIMBS
10%
PRURITUS
10%
FEVER
10%
INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY
10%
INVESTIGATIONS - OTHER, SPECIFY
10%
NEUTROPHIL COUNT DECREASED
10%
WHITE BLOOD CELL DECREASED
10%
ANOREXIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
6%
HYPERHIDROSIS
6%
RASH MACULO-PAPULAR
6%
HERPES SIMPLEX REACTIVATION
6%
CREATININE INCREASED
6%
DRY SKIN
6%
FATIGUE
6%
FLATULENCE
6%
VOMITING
6%
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY
6%
MALAISE
6%
FALL
6%
MYALGIA
6%
LOCALIZED EDEMA
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD BILIRUBIN INCREASED
6%
HYPONATREMIA
6%
ARTHRALGIA
6%
BACK PAIN
6%
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
6%
TUMOR PAIN
6%
CONSTIPATION
3%
Abdominal Pain
3%
Nausea
3%
Vomiting
3%
Cholecystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate)
Standard Dose Treatment (Nelfinavir Mesylate)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nelfinavir mesylate)Experimental Treatment2 Interventions
DOSE NELFINAVIR MESYLATE: Patients receive standard dose nelfinavir mesylate PO BID for 4 weeks in the absence of PD. Patients with PD at 4 weeks proceed to high-dose nelfinavir. At week 8, if there is SD or PR, patients advance to high-dose nelfinavir mesylate. Patients discontinue standard dose nelfinavir mesylate 4 weeks after documentation of CR.
HIGH DOSE NELFINAVIR MESYLATE: Patients with PD continue to receive high-dose nelfinavir mesylate PO BID for 4 more weeks. If there is PD documented after 4 weeks at the high dose level, nelfinavir is discontinued. If there is SD or PR, patients continue receiving nelfinavir mesylate for 16 weeks. If there is CR, patients discontinue high-dose nelfinavir mesylate 4 weeks after documentation of CR.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelfinavir Mesylate
2013
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterOTHER
458 Previous Clinical Trials
588,578 Total Patients Enrolled
University of ArkansasOTHER
496 Previous Clinical Trials
150,355 Total Patients Enrolled
AIDS and Cancer Specimen ResourceOTHER
7 Previous Clinical Trials
949 Total Patients Enrolled
University of California, Los AngelesOTHER
1,569 Previous Clinical Trials
10,314,253 Total Patients Enrolled
AIDS Malignancy ConsortiumLead Sponsor
63 Previous Clinical Trials
9,548 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,544 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,052,102 Total Patients Enrolled
Soren GanttPrincipal InvestigatorAIDS Malignancy Consortium