Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations (NCT NCT02674750)
NCT ID: NCT02674750
Last Updated: 2022-04-27
Results Overview
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
2 Years
Results posted on
2022-04-27
Participant Flow
Adverse Events were collected from signing of the ICF through the last patient visit. (July2016 - May 2019)
Participant milestones
| Measure |
Group A
MYC translocation+ and/or MYC gene copy number gain by FISH
|
Group B
MYC expression in \> 40% of tumor cells by IHC
|
Group C
MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
49
|
16
|
|
Overall Study
COMPLETED
|
0
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
45
|
12
|
Reasons for withdrawal
| Measure |
Group A
MYC translocation+ and/or MYC gene copy number gain by FISH
|
Group B
MYC expression in \> 40% of tumor cells by IHC
|
Group C
MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH
|
|---|---|---|---|
|
Overall Study
Death
|
4
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
8
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
17
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
7
|
1
|
|
Overall Study
Other
|
0
|
8
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations
Baseline characteristics by cohort
| Measure |
Group A
n=5 Participants
MYC translocation+ and/or MYC gene copy number gain by FISH
|
Group B
n=49 Participants
MYC expression in \> 40% of tumor cells by IHC
|
Group C
n=16 Participants
MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
42 participants
n=7 Participants
|
15 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 YearsPopulation: The analysis of ORR was not performed since central radiographic review was not performed, due to inconclusive efficacy at the interim analysis, enrollment was permanently stopped in August 2017.
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Evaluable population; The number of participants in this table include the evaluable participants which is different from the overall number of participants.
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL
Outcome measures
| Measure |
CUDC-907
n=2 Participants
RR-DLBCL, including with MYC alterations detected by FISH or by \>=40% MYC by IHC
CUDC-907
|
Group B
n=28 Participants
MYC expression in \> 40% of tumor cells by IHC
|
Group C
n=9 Participants
MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH
|
|---|---|---|---|
|
Median Progression-free Survival
|
1.2 months
Interval 1.02 to 1.41
|
2.7 months
Interval 1.28 to 4.05
|
2.6 months
Interval 1.28 to 21.94
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Evaluable population; The number of participants in this table include the evaluable participants which is different from the overall number of participants.
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL
Outcome measures
| Measure |
CUDC-907
n=2 Participants
RR-DLBCL, including with MYC alterations detected by FISH or by \>=40% MYC by IHC
CUDC-907
|
Group B
n=28 Participants
MYC expression in \> 40% of tumor cells by IHC
|
Group C
n=9 Participants
MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH
|
|---|---|---|---|
|
Overall Survival (OS)
|
1 participants
|
17 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Evaluable population; The number of participants in this table include the evaluable participants which is different from the overall number of participants.
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL Note: Response is defined using Cheson 2007 criteria. CR=Complete Response; PR=Partial Response; SD=Stable Disease. a. Two-sided exact binomial 95% confidence interval. Revised Response Criteria for Malignant Lymphoma (Cheson 2007) was used for the assessment of response. DCR is defined as the proportion of patients having best response of complete response, partial response, or stable disease.
Outcome measures
| Measure |
CUDC-907
n=2 Participants
RR-DLBCL, including with MYC alterations detected by FISH or by \>=40% MYC by IHC
CUDC-907
|
Group B
n=28 Participants
MYC expression in \> 40% of tumor cells by IHC
|
Group C
n=9 Participants
MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH
|
|---|---|---|---|
|
Disease Control Rate (DCR)
|
0.0 percentage of participants
Interval 0.0 to 84.19
|
46.4 percentage of participants
Interval 27.51 to 66.13
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
SECONDARY outcome
Timeframe: AEs were collected for each participant for the duration that they remained on the study, on average of 4 monthsPopulation: Safety Population; The number of participants in this table include the participants evaluable for safety which is different from the overall number of participants.
Number of participants and severity of adverse events (AEs), serious adverse events (SAEs), and other safety parameters in patients receiving CUDC-907.
Outcome measures
| Measure |
CUDC-907
n=68 Participants
RR-DLBCL, including with MYC alterations detected by FISH or by \>=40% MYC by IHC
CUDC-907
|
Group B
MYC expression in \> 40% of tumor cells by IHC
|
Group C
MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH
|
|---|---|---|---|
|
Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters
Experienced a TEAE leading to D/C
|
11 participants
|
—
|
—
|
|
Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters
Experienced at least 1 study tx-related TEAE
|
59 participants
|
—
|
—
|
|
Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters
Experienced a Grade <3 TEAE
|
52 participants
|
—
|
—
|
|
Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters
Experienced a Grade <3 TEAE tx-related
|
34 participants
|
—
|
—
|
|
Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters
Experienced at least 1 tx emergent SAE
|
30 participants
|
—
|
—
|
|
Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters
Experienced a TEAE with outcome of death
|
17 participants
|
—
|
—
|
|
Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters
Experienced at least 1 TEAE
|
68 participants
|
—
|
—
|
Adverse Events
CUDC-907
Serious events: 30 serious events
Other events: 68 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
CUDC-907
n=68 participants at risk
RR-DLBCL, including with MYC alterations detected by FISH or by \>=40% MYC by IHC
CUDC-907
|
|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.4%
3/68 • Number of events 3 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
General disorders
Asthenia
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
General disorders
Disease Progression
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
General disorders
Pyrexia
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B Cell lymphoma
|
10.3%
7/68 • Number of events 7 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
4.4%
3/68 • Number of events 3 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Gastrointestinal disorders
Diarhhea
|
4.4%
3/68 • Number of events 3 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
2/68 • Number of events 2 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Infections and infestations
Sepsis
|
4.4%
3/68 • Number of events 3 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Infections and infestations
Citrobacter Batremia
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Infections and infestations
Cytomegalovirus
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Infections and infestations
Enterococcal
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Infections and infestations
Pneumonia
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Infections and infestations
Wound infection
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
2/68 • Number of events 2 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Hepatobiliary disorders
hyperbilirubenemia
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
3/68 • Number of events 3 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Nervous system disorders
Gullain-Barre Syndrome
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Product Issues
Device occulsion
|
1.5%
1/68 • Number of events 1 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
Other adverse events
| Measure |
CUDC-907
n=68 participants at risk
RR-DLBCL, including with MYC alterations detected by FISH or by \>=40% MYC by IHC
CUDC-907
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
72.1%
49/68 • Number of events 49 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Gastrointestinal disorders
Nausea
|
48.5%
33/68 • Number of events 33 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Gastrointestinal disorders
Vomiting
|
27.9%
19/68 • Number of events 19 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Gastrointestinal disorders
Constipation
|
20.6%
14/68 • Number of events 14 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.6%
12/68 • Number of events 12 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
4/68 • Number of events 4 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
General disorders
Fatigue
|
35.3%
24/68 • Number of events 24 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
General disorders
Pyrexia
|
19.1%
13/68 • Number of events 13 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
General disorders
Peripheral edema
|
11.8%
8/68 • Number of events 8 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
General disorders
Asthensia
|
7.4%
5/68 • Number of events 5 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
General disorders
Chills
|
5.9%
4/68 • Number of events 4 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
54.4%
37/68 • Number of events 37 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.8%
23/68 • Number of events 23 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Metabolism and nutrition disorders
Hypomagnesia
|
39.7%
27/68 • Number of events 27 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
27.9%
19/68 • Number of events 19 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.6%
12/68 • Number of events 12 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
19.1%
13/68 • Number of events 13 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
41.2%
28/68 • Number of events 28 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Blood and lymphatic system disorders
Anemia
|
26.5%
18/68 • Number of events 18 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.6%
14/68 • Number of events 14 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.5%
18/68 • Number of events 18 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.2%
9/68 • Number of events 9 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
8.8%
6/68 • Number of events 6 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.6%
14/68 • Number of events 14 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.1%
13/68 • Number of events 13 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.2%
11/68 • Number of events 11 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.8%
6/68 • Number of events 6 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Nervous system disorders
Dizziness
|
19.1%
13/68 • Number of events 13 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Nervous system disorders
Headache
|
8.8%
6/68 • Number of events 6 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Nervous system disorders
Dysgeusia
|
7.4%
5/68 • Number of events 5 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Infections and infestations
Upper Respiratory Infection
|
8.8%
6/68 • Number of events 6 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Infections and infestations
Sepsis
|
5.9%
4/68 • Number of events 4 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
5/68 • Number of events 5 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
16.2%
11/68 • Number of events 11 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B Cell lymphoma
|
10.3%
7/68 • Number of events 7 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Cardiac disorders
Atrial fibrillation
|
7.4%
5/68 • Number of events 5 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
|
Psychiatric disorders
Insomnia
|
5.9%
4/68 • Number of events 4 • AEs were collected for each participant for the duration that they remained on the study, on average of 4 months
|
Additional Information
Reinhard von Roemeling, M.D., Senior Vice President, Clinical Development
Curis, Inc.
Phone: 617-503-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER