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Bcl-2 inhibitor

Navitoclax for Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Christine L Hann
Research Sponsored by National Cancer Institute (NCI)
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 1.5 years
Awards & highlights

Study Summary

This trial is testing navitoclax + vistusertib to see if it's more effective than navitoclax alone in treating patients with small cell lung cancer or solid tumors that have come back.

Eligible Conditions
  • Small Cell Lung Cancer
  • Lung Small Cell Carcinoma
  • Solid Tumors
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose Limiting Toxicities (Phase I)
Overall Response Rate (ORR) (Phase II)
Secondary outcome measures
Disease Control Rate (Phase II)
Number of Participants Experiencing Adverse Events by Grade (Phase II)
Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction
+2 more
Other outcome measures
Change in BAX and MCl-1 Expression
Change in Ratio p4EBP1/4EBP1
Change in Ratio pS6/S6
+2 more

Side effects data

From 2022 Phase 1 & 2 trial • 60 Patients • NCT00481091
75%
DIARRHOEA
50%
VOMITING
50%
COUGH
50%
HERPES SIMPLEX
50%
NAUSEA
50%
FATIGUE
50%
UPPER RESPIRATORY TRACT INFECTION
50%
DECREASED APPETITE
25%
NEURALGIA
25%
PRODUCTIVE COUGH
25%
GASTROENTERITIS SALMONELLA
25%
NEUTROPENIA
25%
LYMPHADENOPATHY
25%
VENTRICULAR EXTRASYSTOLES
25%
PYREXIA
25%
ABDOMINAL PAIN
25%
CONSTIPATION
25%
EYE INFECTION
25%
CELLULITIS
25%
PNEUMONITIS
25%
SUPERFICIAL SPREADING MELANOMA STAGE UNSPECIFIED
25%
THROMBOCYTOPENIA
25%
INFLUENZA LIKE ILLNESS
25%
VIRAL INFECTION
25%
NASOPHARYNGITIS
25%
ORAL HERPES
25%
CONTUSION
25%
DEHYDRATION
25%
LIMB DISCOMFORT
25%
NEUROPATHY PERIPHERAL
25%
DYSPNOEA
25%
LETHARGY
25%
SINUS CONGESTION
25%
WHEEZING
25%
COLD SWEAT
25%
LOWER RESPIRATORY TRACT INFECTION
25%
DYSPEPSIA
25%
CHEST PAIN
25%
FEELING HOT
25%
OEDEMA PERIPHERAL
25%
HYPOMAGNESAEMIA
25%
SECRETION DISCHARGE
25%
ALLERGY TO ARTHROPOD BITE
25%
INFLUENZA
25%
SINUSITIS
25%
BACK PAIN
25%
OSTEOPENIA
25%
BASAL CELL CARCINOMA
25%
SQUAMOUS CELL CARCINOMA OF SKIN
25%
HEADACHE
25%
OROPHARYNGEAL PAIN
25%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Navitoclax 21/21 Day Cycle: 200 mg
Phase 2: Navitoclax 100 mg
Navitoclax 14/21 Day Cycle: 200 mg
Navitoclax 21/21 Day Cycle: 125 mg
Navitoclax 14/21 Day Cycle: 250 mg
Navitoclax 21/21 Day Cycle: 250 mg
Phase 2: Navitoclax 250 mg
Navitoclax 21/21 Day Cycle: 300 mg
Navitoclax 14/21 Day Cycle: 10 mg
Navitoclax 14/21 Day Cycle: 110 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (navitoclax, vistusertib)Experimental Treatment2 Interventions
Patients receive navitoclax PO QD and vistusertib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Navitoclax
2012
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,257 Total Patients Enrolled
Christine L HannPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors
2018. "Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03366103.
~2 spots leftby Apr 2025
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