DKN-01 for Biliary Tract Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Massachusetts General Hospital Cancer Center, Boston, MABiliary Tract CancerDKN-01 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination treatment for advanced biliary tract cancer.

Eligible Conditions
  • Biliary Tract Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From the time of randomization until death, up to approximately 5 years

Year 3
Overall Response Rate
Year 5
Median Overall Survival
Year 5
Median Progression Free Survival

Trial Safety

Safety Progress

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

Side Effects for

300 mg DKN-01 Part A
75%FATIGUE
50%NAUSEA
25%DECREASED APPETITE
25%VOMITTING
25%VOMITING
25%PAIN MANAGEMENT
25%ASTHENIA
25%CONSTIPATION
This histogram enumerates side effects from a completed 2013 Phase 1 trial (NCT01457417) in the 300 mg DKN-01 Part A ARM group. Side effects include: FATIGUE with 75%, NAUSEA with 50%, DECREASED APPETITE with 25%, VOMITTING with 25%, VOMITING with 25%.

Trial Design

2 Treatment Groups

DKN 01 and Nivolumab
1 of 2
DKN 01 and Nivolumab Safety Run in
1 of 2

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: DKN-01 · No Placebo Group · Phase 2

DKN 01 and NivolumabExperimental Group · 2 Interventions: Nivolumab, DKN-01 · Intervention Types: Drug, Drug
DKN 01 and Nivolumab Safety Run inExperimental Group · 2 Interventions: Nivolumab, DKN-01 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
DKN-01
2015
Completed Phase 1
~240

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the time of randomization until death, up to approximately 5 years

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,510 Previous Clinical Trials
3,944,313 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,726 Previous Clinical Trials
31,219,557 Total Patients Enrolled
Leap Therapeutics, Inc.Industry Sponsor
15 Previous Clinical Trials
1,012 Total Patients Enrolled
Lipika Goyal, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
59 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 21 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your doctor expects you to live for more than 3 months.

Frequently Asked Questions

How many individuals are included in this research?

"That is correct. The latest information from clinicaltrials.gov says that this study, which began recruitment on October 7th 2019, is still looking for candidates. They need 30 people total, at 2 different locations." - Anonymous Online Contributor

Unverified Answer

What is the DKN-01 drug's official standing with the FDA?

"DKN-01 has not yet been proven effective, however, there is some data supporting its safety which gives it a ranking of 2." - Anonymous Online Contributor

Unverified Answer

Is this research novel in any way?

"DKN-01 has a long history, with the first clinical study being performed a decade ago in 2010. The original trial was sponsored by Medarex and only involved 127 patients. DKN-01 received Phase 1 approval after this initial study. As of now, there are 747 active studies involving DKN-01 located in 2347 cities across 50 countries." - Anonymous Online Contributor

Unverified Answer

Are investigators actively looking for participants for this research project?

"The trial is currently recruiting patients, as indicated by the information on clinicaltrials.gov. This study was originally posted on October 7th, 2019 and has been edited recently on January 24th, 2021." - Anonymous Online Contributor

Unverified Answer

What other data is available on DKN-01?

"Currently, there are 747 clinical trials studying DKN-01. 82 of those live clinical trials are in Phase 3. While the many trials for DKN-01 are based in Basel, BE, there are 40324 locations running studies for this treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary reason that DKN-01 is prescribed?

"DKN-01 is most often used to treat malignant neoplasms, but it can also be prescribed for conditions like metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanoma." - 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.