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Trial record 1 of 4 for:    LY2812176
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A Study of DKN-01 in Multiple Myeloma or Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leap Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01457417
First received: October 18, 2011
Last updated: September 26, 2016
Last verified: September 2016
Results First Received: January 13, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Solid Tumors
Non-Small Cell Lung Cancer
Intervention: Drug: DKN-01

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eight sites in the United States participated in the study and 7 of them enrolled patients. The Date of First Enrollment was 16 Jan 2012, and the Date of Last Completed was 06 Dec 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Part A enrolled patients with histologically or cytologically confirmed multiple myeloma or advanced solid tumors. A dose escalation procedure was followed. Part B enrolled patients with non-small cell lung cancer. Following screening (up to 28 days prior to first treatment) if entry criterion was met, patients were eligible for enrollment.

Reporting Groups
  Description
75 Milligram (mg) DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
150 mg DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
300 mg DKN-01 Part A (QW) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
600 mg DKN-01 Part A (Q2W) DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
300 mg DKN-01 Part B (Q2W) Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.

Participant Flow:   Overall Study
    75 Milligram (mg) DKN-01 Part A (QW)     150 mg DKN-01 Part A (QW)     300 mg DKN-01 Part A (QW)     600 mg DKN-01 Part A (Q2W)     300 mg DKN-01 Part B (Q2W)  
STARTED     3     3     4     3     19  
COMPLETED     3     3     4     3     19  
NOT COMPLETED     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
75 Milligram (mg) DKN-01 Part A DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
150 mg DKN-01 Part A DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
300 mg DKN-01 Part A DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
600 mg DKN-01 Part A DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
300 mg DKN-01 Part B Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
Total Total of all reporting groups

Baseline Measures
    75 Milligram (mg) DKN-01 Part A     150 mg DKN-01 Part A     300 mg DKN-01 Part A     600 mg DKN-01 Part A     300 mg DKN-01 Part B     Total  
Number of Participants  
[units: participants]
  3     3     4     3     19     32  
Age  
[units: years]
Mean (Standard Deviation)
  57.7  (7.77)     66.3  (8.62)     65.0  (19.20)     68.3  (8.96)     65.4  (9.25)     65.0  (10.29)  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     3     1     2     1     10     17  
>=65 years     0     2     2     2     9     15  
Gender  
[units: participants]
           
Female     1     3     4     1     9     18  
Male     2     0     0     2     10     14  
Region of Enrollment  
[units: participants]
           
United States     3     3     4     3     19     32  



  Outcome Measures
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1.  Primary:   Summary of Total Adverse Events (AE)   [ Time Frame: Baseline to study completion (approximately 3 months) ]

2.  Primary:   Summary of Patients With Adverse Events (AE)   [ Time Frame: Baseline to study completion (approximately 3 months) ]

3.  Primary:   Progression Free Survival (PFS) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)   [ Time Frame: Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause ]

4.  Secondary:   Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01   [ Time Frame: Cycle 1 Day 1 (first dose, all groups) ]

5.  Secondary:   Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01   [ Time Frame: Cycle 1 Day 22 (Fourth Dose for QW) ]

6.  Secondary:   Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01   [ Time Frame: Cycle 1 Day 1 (first dose, all groups) ]

7.  Secondary:   Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01   [ Time Frame: Cycle 1 Day 22 (Fourth dose for QW groups) ]

8.  Secondary:   Progression Free Survival (PFS) in Patients Who Are Refractory or Intolerant to Standard/Approved Therapies   [ Time Frame: Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause ]

9.  Secondary:   Overall Survival (OS) in Patients With Relapsed or Refractory NSCLC   [ Time Frame: Time from the date of signed informed consent to the date of death from any cause ]

10.  Secondary:   Objective Response Rate (ORR) in Oncologic Patients Who Are Refractory or Intolerant to Standard/Approved Therapies   [ Time Frame: Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter ]

11.  Secondary:   Objective Response Rate (ORR) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)   [ Time Frame: Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Cynthia Sirard, MD
Organization: Healthcare Pharmaceuticals, Inc
phone: 617-714-0357
e-mail: CSirard@hcven.com



Responsible Party: Leap Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01457417     History of Changes
Other Study ID Numbers: P100
DEK-DKK1-P100 ( Other Identifier: Healthcare Pharmaceuticals )
LY2812176 ( Other Identifier: Healthcare Pharmaceuticals )
Study First Received: October 18, 2011
Results First Received: January 13, 2015
Last Updated: September 26, 2016
Health Authority: United States: Food and Drug Administration