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Onvansertib for Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UPMC Hillman Cancer Center, Pittsburgh, PASmall Cell Lung Cancer+1 MoreOnvansertib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study whether onvansertib is safe and effective at treating small cell lung cancer in patients who can't tolerate or haven't responded to chemotherapy.

Eligible Conditions
  • Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Flt3/MerTK Inhibitor MRX-2843
1
Onvansertib
1
Cisplatin

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 3.5 years

Up to 3.5 years
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Overall survival (OS)
Progression-free survival (PFS)
Month 42
Objective Response Rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Flt3/MerTK Inhibitor MRX-2843
1
Onvansertib
1
Cisplatin

Side Effects for

Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine
40%Febrile neutropenia
40%Oedema peripheral
40%Ecchymosis
40%Confusional state
20%Lung infection
20%Dry skin
20%Asthenia
20%Fatigue
20%Lethargy
20%Pleural effusion
20%Respiratory failure
20%Oropharyngeal pain
20%Dermatitis bullous
20%Blood bilirubin increased
20%Laceration
20%Diarrhoea
20%Stomatitis
20%Cough
20%Alopecia
20%Erythema
20%Blood alkaline phosphatase
20%Agitation
20%Fall
20%Pain
20%Dyspnoea exertional
20%Decreased appetite
20%Cellulitis
20%Alanine aminotransferase increased
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT03303339) in the Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine ARM group. Side effects include: Febrile neutropenia with 40%, Oedema peripheral with 40%, Ecchymosis with 40%, Confusional state with 40%, Lung infection with 20%.

Trial Design

1 Treatment Group

Single Treatment Arm
1 of 1

Experimental Treatment

37 Total Participants · 1 Treatment Group

Primary Treatment: Onvansertib · No Placebo Group · Phase 2

Single Treatment Arm
Drug
Experimental Group · 1 Intervention: Onvansertib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onvansertib
2017
Completed Phase 2
~80

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3.5 years

Who is running the clinical trial?

Taofeek OwonikokoLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,477 Previous Clinical Trials
24,586,269 Total Patients Enrolled
Cardiff OncologyIndustry Sponsor
8 Previous Clinical Trials
536 Total Patients Enrolled
Taofeek Owonikoko, MD, PhDPrincipal InvestigatorUPMC Hillman Cancer Center
5 Previous Clinical Trials
173 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Rewritten Criterion: You are able to swallow pills or tablets.
References

Frequently Asked Questions

Are we currently looking for more participants for this clinical trial?

"The trial, which was originally posted on 7/19/2022 and updated last on 7/29/2022, is presently recruiting patients as reported by clinicaltrials.gov" - Anonymous Online Contributor

Unverified Answer

How many volunteers are currently enrolled in this experiment?

"Indeed, the trial is presently recruiting patients as indicated by information on clinicaltrials.gov. The original posting was on 7/19/2022 and there have been 37 edits as of 7/29/2022. Currently, 1 sites are looking for participants." - Anonymous Online Contributor

Unverified Answer

What are the potential Onvansertib side effects that patients should be aware of?

"Onvansertib's safety is supported by some data, but since this is only a Phase 2 trial, there is no evidence yet of its efficacy. Therefore, it received a score of 2." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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