Treatment for Colorectal Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Colorectal Carcinoma+3 More
DKN-01 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer drug, DKN-01, to see if it is more effective than the current standard of care for treating advanced colorectal cancer.

Eligible Conditions
  • Colorectal Carcinoma
  • Metastatic Colorectal Cancer (CRC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: approximately 6 months

approximately 6 months
Disease control rate (DCR)
Durable clinical benefit (DCB)
Duration of Complete Response (DoCR)
Duration of Response (DoR)
Duration of clinical benefit (DoCB)
Exposure-response relationships for DKN-01 as data permit.
Incidence of ≥Grade 3 related treatment-related adverse events (TRAEs).
Objective Response Rate (ORR)
Overall Survival (OS)
PFS
Progression Free Survival (PFS)
Time to response (TTR)

Trial Safety

Safety Progress

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

Similar Trials

Trial Design

2 Treatment Groups

Control
1 of 2
Treatment
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment · No Placebo Group · Phase 2

TreatmentExperimental Group · 4 Interventions: DKN-01, FOLFIRI, Bevacizumab, FOLFOX · Intervention Types: Drug, Drug, Drug, Drug
ControlActiveComparator Group · 3 Interventions: FOLFIRI, Bevacizumab, FOLFOX · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DKN-01
2015
Completed Phase 1
~240
FOLFIRI
2005
Completed Phase 3
~5980
Bevacizumab
2014
Completed Phase 4
~5320
FOLFOX
2009
Completed Phase 3
~3760

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 6 months

Who is running the clinical trial?

Leap Therapeutics, Inc.Lead Sponsor
14 Previous Clinical Trials
672 Total Patients Enrolled
Cynthia Sirard, MDStudy DirectorLeap Therapeutics, Inc.
2 Previous Clinical Trials
183 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: November 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.