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A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882803
Recruitment Status : Active, not recruiting
First Posted : June 20, 2013
Results First Posted : November 20, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Indolent Non-Hodgkin Lymphoma
Intervention Drug: Duvelisib
Enrollment 129
Recruitment Details This multicenter, multinational study enrolled subjects at 56 medical clinics across 12 countries.
Pre-assignment Details  
Arm/Group Title Duvelisib
Hide Arm/Group Description Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 129
Completed 35 [1]
Not Completed 94
Reason Not Completed
Disease Progression             53
Adverse Event             22
Death             7
Physician Decision             7
Protocol Violation             1
Withdrawal by Subject             4
[1]
Subject received treatment in 28-day cycles until disease progression or unacceptable toxicity.
Arm/Group Title Duvelisib
Hide Arm/Group Description Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
<=18 years
0
   0.0%
Between 18 and 65 years
64
  49.6%
>=65 years
65
  50.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants
63.6  (11.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
Female
41
  31.8%
Male
88
  68.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
Hispanic or Latino
3
   2.3%
Not Hispanic or Latino
118
  91.5%
Unknown or Not Reported
8
   6.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
American Indian or Alaskan Native
1
   0.8%
Asian
1
   0.8%
Black or African American
6
   4.7%
Native Hawaiian or other Pacific Islander
0
   0.0%
White
116
  89.9%
Other
1
   0.8%
Unknown
2
   1.6%
Missing
2
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 129 participants
Hungary 7
United States 46
Czechia 9
United Kingdom 11
Belarus 10
Spain 2
Canada 9
Belgium 2
Italy 21
Georgia 1
France 6
Bulgaria 5
1.Primary Outcome
Title Overall Response Rate (ORR) in All Subjects During Treatment With Duvelisib Based on Standard Response.
Hide Description Summary of Best Overall Response and Overall Response Rate per IRC Assessment (FAS)
Time Frame Every 8-16 weeks while on treatment with duvelisib; an expected average on-treatment duration of response follow-up of 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Duvelisib
Hide Arm/Group Description:
Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 129
Measure Type: Count of Participants
Unit of Measure: Participants
59
  45.7%
2.Secondary Outcome
Title Number of Subjects With Treatment- Emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
Hide Description Treatment-Emergent Adverse Events Occurring in ≥ 10% Subjects, by SOC and PT (FAS)
Time Frame Every 2-8 weeks; up to 30 days after the last dose of duvelisib.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with at Least 1 TEAE
Arm/Group Title Duvelisib
Hide Arm/Group Description:
Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 129
Measure Type: Count of Participants
Unit of Measure: Participants
128
  99.2%
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of Response per IRC Full Analysis Set
Time Frame Every 8-16 weeks; for an average duration of response follow-up of 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of Response per IRC Full Analysis Set
Arm/Group Title Duvelisib
Hide Arm/Group Description:
Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 129
Median (95% Confidence Interval)
Unit of Measure: months
9.9
(4.5 to 10.3)
4.Secondary Outcome
Title Progression-free Survival
Hide Description Progression Free Survival per IRC Full Analysis Set
Time Frame Every 8-16 weeks; for an average response / progression follow-up of 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Kaplan-Meier Event-Free Estimate (95% Confidence Interval)
Arm/Group Title Duvelisib
Hide Arm/Group Description:
Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 129
Median (95% Confidence Interval)
Unit of Measure: months
8.4
(5.8 to 11.3)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival Full Analysis Set
Time Frame Every 16 weeks; for an average survival follow-up of 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Overall Survival Full Analysis Set
Arm/Group Title Duvelisib
Hide Arm/Group Description:
Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 129
Median (95% Confidence Interval)
Unit of Measure: months
18.4 [1] 
(15.7 to NA)
[1]
NA = The upper limit of the confidence interval is not estimable because an insufficient number of events have occurred at the time of analysis.
6.Secondary Outcome
Title PK Plasma Concentrations of Duvelisib and Its Metabolite(s)
Hide Description Pharmacokinetics - duvelisib concentration (ng/mL) Full Analysis Set
Time Frame Every 4 weeks for 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics - duvelisib and IPI-656 concentration (ng/mL) Full Analysis Set
Arm/Group Title Duvelisib IPI-656
Hide Arm/Group Description:
Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
IPI-656 concentration (ng/mL) Full Analysis Set
Overall Number of Participants Analyzed 129 129
Median (Full Range)
Unit of Measure: ng/mL
C1D15 Predose Number Analyzed 117 participants 117 participants
414
(19 to 4590)
648
(116 to 6010)
C1D15 1 hour post dose Number Analyzed 118 participants 118 participants
1175
(206 to 6820)
641
(160 to 5920)
C1D15 4 hours post dose Number Analyzed 129 participants 118 participants
852
(233 to 5170)
714
(230 to 6020)
C2D1 Number Analyzed 129 participants 117 participants
631 [1] 
(NA to 4180)
704 [1] 
(NA to 10200)
C3D1 Number Analyzed 110 participants 110 participants
696 [1] 
(NA to 3540)
664 [1] 
(NA to 6850)
[1]
<LLOQ
7.Secondary Outcome
Title Time to Response (TTR)
Hide Description Time to Response per IRC Full Analysis Set
Time Frame First dose to first documentation of complete or partial response
Hide Outcome Measure Data
Hide Analysis Population Description
Time to Response per IRC Full Analysis Set
Arm/Group Title Duvelisib
Hide Arm/Group Description:
Duvelisib: PI3K Inhibitor Study IPI-145-06 is an open-label, single-arm efficacy and safety study. Subjects received a dose of 25 mg duvelisib BID over the course of 28-day treatment cycles until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 129
Measure Type: Number
Unit of Measure: participants
<2 months 36
2 - <3 months 5
3 - <4 months 10
4 - <5 months 2
5 - <6 months 5
>=6 months 1
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duvelisib
Hide Arm/Group Description Duvelisib: PI3K Inhibitor
All-Cause Mortality
Duvelisib
Affected / at Risk (%)
Total   37/129 (28.68%) 
Hide Serious Adverse Events
Duvelisib
Affected / at Risk (%)
Total   74/129 (57.36%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  9/129 (6.98%) 
Pancytopenia  1  3/129 (2.33%) 
Anaemia  1  2/129 (1.55%) 
Thrombocytopenia  1  2/129 (1.55%) 
Lymph node pain  1  1/129 (0.78%) 
Cardiac disorders   
Atrial fibrillation  1  1/129 (0.78%) 
Cardiac failure  1  1/129 (0.78%) 
Cardiac failure congestive  1  1/129 (0.78%) 
Coronary artery occlusion  1  1/129 (0.78%) 
Pericarditis  1  1/129 (0.78%) 
Gastrointestinal disorders   
Diarrhoea  1  9/129 (6.98%) 
Colitis  1  5/129 (3.88%) 
Abdominal pain  1  2/129 (1.55%) 
Enterocolitis  1  2/129 (1.55%) 
Vomiting  1  2/129 (1.55%) 
Abdominal mass  1  1/129 (0.78%) 
Duodenitis  1  1/129 (0.78%) 
Enteritis  1  1/129 (0.78%) 
Nausea  1  1/129 (0.78%) 
Oesophagitis  1  1/129 (0.78%) 
Pancreatitis acute  1  1/129 (0.78%) 
General disorders   
Disease progression  1  8/129 (6.20%) 
Pyrexia  1  4/129 (3.10%) 
Fatigue  1  1/129 (0.78%) 
Hepatobiliary disorders   
Cholecystitis  1  1/129 (0.78%) 
Hyperbilirubinaemia  1  1/129 (0.78%) 
Infections and infestations   
Pneumonia  1  5/129 (3.88%) 
Bronchopneumonia  1  3/129 (2.33%) 
Bronchopulmonary aspergillosis  1  1/129 (0.78%) 
Cellulitis  1  1/129 (0.78%) 
Clostridium difficile colitis  1  1/129 (0.78%) 
Cystitis pseudomonal  1  1/129 (0.78%) 
Diverticulitis  1  1/129 (0.78%) 
Escherichia sepsis  1  1/129 (0.78%) 
Gastroenteritis  1  1/129 (0.78%) 
Infective myositis  1  1/129 (0.78%) 
Influenza  1  1/129 (0.78%) 
Klebsiella sepsis  1  1/129 (0.78%) 
Lower respiratory tract infection  1  1/129 (0.78%) 
Neutropenic sepsis  1  1/129 (0.78%) 
Oral candidiasis * 1  1/129 (0.78%) 
Oropharyngeal candidiasis  1  1/129 (0.78%) 
Pneumocystis jirovecii pneumonia  1  1/129 (0.78%) 
Pneumonia cytomegaloviral  1  1/129 (0.78%) 
Pneumonia pseudomonas aeruginosa  1  1/129 (0.78%) 
Pseudomembranous colitis  1  1/129 (0.78%) 
Pseudomonal bacteraemia  1  1/129 (0.78%) 
Pseudomonal sepsis  1  1/129 (0.78%) 
Pyelonephritis acute  1  1/129 (0.78%) 
Scrotal infection  1  1/129 (0.78%) 
Sepsis  1  1/129 (0.78%) 
Sepsis syndrome  1  1/129 (0.78%) 
Septic shock  1  1/129 (0.78%) 
Urinary tract infection  1  1/129 (0.78%) 
Viral infection  1  1/129 (0.78%) 
Vulval cellulitis  1  1/129 (0.78%) 
Injury, poisoning and procedural complications   
Infusion related reaction  1  1/129 (0.78%) 
Spinal compression fracture  1  1/129 (0.78%) 
Investigations   
Alanine aminotransferase increased  1  1/129 (0.78%) 
Blood creatinine increased  1  1/129 (0.78%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  2/129 (1.55%) 
Hypercalcaemia  1  1/129 (0.78%) 
Hyperkalaemia  1  1/129 (0.78%) 
Hypoglycaemia  1  1/129 (0.78%) 
Hyponatraemia  1  1/129 (0.78%) 
Musculoskeletal and connective tissue disorders   
Rhabdomyolysis  1  1/129 (0.78%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma of skin  1  2/129 (1.55%) 
Acute myeloid leukaemia  1  1/129 (0.78%) 
Malignant Melanoma  1  1/129 (0.78%) 
Myelodysplastic syndrome  1  1/129 (0.78%) 
Neuroendocrine carcinoma of the skin  1  1/129 (0.78%) 
Non-small cell lung cancer  1  1/129 (0.78%) 
Nervous system disorders   
Transient ischaemic attack  1  1/129 (0.78%) 
Renal and urinary disorders   
Renal failure acute  1  3/129 (2.33%) 
Renal failure  1  2/129 (1.55%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  3/129 (2.33%) 
Pneumonitis  1  2/129 (1.55%) 
Respiratory disorder  1  1/129 (0.78%) 
Skin and subcutaneous tissue disorders   
Rash  1  2/129 (1.55%) 
Rash generalised  1  2/129 (1.55%) 
Dermatitis allergic * 1  1/129 (0.78%) 
Dermatitis exfoliative  1  1/129 (0.78%) 
Drug reaction with eosinophilia and systemic symptoms  1  1/129 (0.78%) 
Toxic epidermal necrolysis  1  1/129 (0.78%) 
Vascular disorders   
Deep vein thrombosis  1  1/129 (0.78%) 
Embolism  1  1/129 (0.78%) 
Peripheral embolism  1  1/129 (0.78%) 
Superior vena cava syndrome  1  1/129 (0.78%) 
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Duvelisib
Affected / at Risk (%)
Total   128/129 (99.22%) 
Blood and lymphatic system disorders   
Neutropenia  1  34/129 (26.36%) 
Thrombocytopenia  1  20/129 (15.50%) 
Anaemia  1  28/129 (21.71%) 
Gastrointestinal disorders   
Diarrhoea  1  57/129 (44.19%) 
Nausea  1  37/129 (28.68%) 
Vomiting  1  20/129 (15.50%) 
Abdominal pain  1  15/129 (11.63%) 
Constipation  1  15/129 (11.63%) 
Dry mouth  1  9/129 (6.98%) 
Stomatitis  1  8/129 (6.20%) 
General disorders   
Fatigue  1  31/129 (24.03%) 
Pyrexia  1  26/129 (20.16%) 
Oedema peripheral  1  19/129 (14.73%) 
Asthenia  1  14/129 (10.85%) 
Chills  1  7/129 (5.43%) 
Infections and infestations   
Oral Candidiasis  1  7/129 (5.43%) 
Investigations   
Alanine aminotransferase increased  1  17/129 (13.18%) 
Aspartate aminotransferase increased  1  13/129 (10.08%) 
Lipase increased  1  11/129 (8.53%) 
Weight decreased  1  9/129 (6.98%) 
Blood alkaline phosphatase increased  1  7/129 (5.43%) 
Blood creatinine increased  1  7/129 (5.43%) 
Neutrophil count decreased  1  7/129 (5.43%) 
Metabolism and nutrition disorders   
Decreased appetite  1  19/129 (14.73%) 
Hypokalaemia  1  15/129 (11.63%) 
Dehydration  1  7/129 (5.43%) 
Hyperuricaemia  1  7/129 (5.43%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  17/129 (13.18%) 
Arthralgia  1  16/129 (12.40%) 
Pain in extremity  1  11/129 (8.53%) 
Musculoskeletal pain  1  7/129 (5.43%) 
Nervous system disorders   
Headache  1  19/129 (14.73%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  31/129 (24.03%) 
Dyspnoea  1  10/129 (7.75%) 
Oropharyngeal pain  1  8/129 (6.20%) 
Skin and subcutaneous tissue disorders   
Rash  1  21/129 (16.28%) 
Night sweats  1  11/129 (8.53%) 
Pruritus  1  11/129 (8.53%) 
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gloria Patrick
Organization: Verastem Oncology
Phone: 781-469-1594
EMail: gpatrick@verastem.com
Layout table for additonal information
Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT01882803    
Other Study ID Numbers: IPI-145-06
First Submitted: May 31, 2013
First Posted: June 20, 2013
Results First Submitted: October 23, 2018
Results First Posted: November 20, 2018
Last Update Posted: May 15, 2020