NCT02314052 is a Phase 1, PHASE2 clinical trial of DCR-MYC in Hepatocellular Carcinoma, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.

Who is sponsoring NCT02314052?

NCT02314052 is sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.

What drugs are being tested in NCT02314052?

Interventions in NCT02314052: DCR-MYC.

What condition does NCT02314052 study?

NCT02314052 studies Hepatocellular Carcinoma.

Is NCT02314052 still recruiting?

NCT02314052 is currently terminated. Last updated 11 July 2024.

Are results published for NCT02314052?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-11 · How we verify

NCT02314052

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase Ib/2, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Hepatocellular Carcinoma

Terminated Phase 1, PHASE2 Results posted Last updated 11 July 2024

What this trial tests

Phase 1, PHASE2 trial testing DCR-MYC in Hepatocellular Carcinoma in 21 participants. Terminated before completion.

Timeline

27 January 2015

Primary endpoint
11 October 2016

11 October 2016

Quick facts

Lead sponsor	Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	27 January 2015
Primary completion	11 October 2016
Estimated completion	11 October 2016
Sites	6 locations across Singapore, United States, South Korea

Drugs / interventions tested

DCR-MYC — full drug profile →

Conditions studied

Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company — full company profile →

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase 1b: Number of Patients With Adverse Events as a Measure of Safety and Tolerability Primary · Cycle 1 (3 weeks), longer if DCR-MYC is continued; with 30 days follow-up after last dose

Part A: 3 patient cohorts with 50% dose increase between cohorts until study drug-related dose-limiting toxicity (DLT) during Cycle 1, then expand to 6 patients and move to Part B. Part B: 3 to 6 patient cohorts with 25% dose increase between cohorts until \> 1 study drug-related DLT, then stop escalation. Expand MTD cohort to 12 patients; tumor biopsies to be performed in this Phase 1b MTD Biopsy Cohort (6 patients).

Group	Value	95% CI
Cohort 1	3
Cohort 2	3
Cohort 3	3
Cohort 4	3
Cohort 5	6
Cohort 6	3

Cmax (ng/mL) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8 Secondary · Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4

Samples to be collected Week 1 (Day 1, 2, and 4) and Week 2 (Day 8 and 11). A summary of outcome measures reported here are noncompartmental PK parameters (Cmax, dose-normalized Cmax (Cmax\_D), Tmax, AUClast, and dose-normalized AUClast (AUClast\_D)) for both infusion days (Day 1 and Day 8).

Cmax: Day 1

Group	Value	95% CI
Cohort 1	2094.3	± 1257.8
Cohort 2	4790.5	± 3540.2
Cohort 3	6195.7	± 744.75
Cohort 4	9807.1	± 4094.5
Cohort 5	19399	± 8211.4
Cohort 6	19829	± 3686.2

Cmax: Day 8

Group	Value	95% CI
Cohort 1	1755.7	± 59.47
Cohort 2	5504.9	± 3365.3
Cohort 3	6628.4	± 1155.8
Cohort 4	13484	± 2576.2
Cohort 5	20711	± 13768
Cohort 6	27067	± 9105.1

DCR-MYC Biological Activities (Phase 1b Only) Secondary · Cycle 1; Week 1

Collection of blood samples for cytokine measurements (Day 1, 2, and 4). No noteworthy increases were observed across dose groups or time for GM-CSF, IFNα, IFNɣ, or IL-1β. Changes that were observed for the other cytokines were not dose-dependent since they occurred sporadically and primarily in Cohorts 3 (0.3 mg/kg) and 4 (0.45 mg/kg). Pre-dose, 4 hours post-dose, and 24 hour post-dose results for TNF-α, IL-10, IL-6, IL-8, IL-1RA, and MCP-1 are summarized here.

TNF-α Pre-dose

Group	Value	95% CI
Cohort 1	2.3	± 1.3
Cohort 2	1.6	± 0
Cohort 3	4.1	± 0.7
Cohort 4	1.6	± 0
Cohort 5	3.1	± 3.0
Cohort 6	1.6	± 0

TNF-α 4 hour post-dose

Group	Value	95% CI
Cohort 1	1.6	± 0
Cohort 2	1.6	± 0
Cohort 3	15.9	± 16.6
Cohort 4	23.1	± 34.2
Cohort 5	1.6	± 0
Cohort 6	1.6	± 0

TNF-α 24 hour post-dose

Group	Value	95% CI
Cohort 1	1.6	± 0
Cohort 2	4.1	± 0.5
Cohort 3	4.5	± 1.2
Cohort 4	3.3	± 2.9
Cohort 5	2.4	± 1.7
Cohort 6	3.8	± 3.8

IL-10 pre-dose

Group	Value	95% CI
Cohort 1	317.5	± 60.9
Cohort 2	239.4	± 83.7
Cohort 3	741.1	± 46.7
Cohort 4	574.3	± 341.0
Cohort 5	670.2	± 369.4
Cohort 6	599.7	± 333.8

IL-10 4 hour post

Group	Value	95% CI
Cohort 1	241.1	± 61.3
Cohort 2	159.6	± 104.2
Cohort 3	933.1	± 427.2
Cohort 4	1316.7	± 1617.7
Cohort 5	527.1	± 225.5
Cohort 6	533.7	± 265.6

IL-10 24 hour post

Group	Value	95% CI
Cohort 1	322.5	± 152.9
Cohort 2	424.4	± 296.4
Cohort 3	939.3	± 939.3
Cohort 4	667.7	± 362.7
Cohort 5	541.8	± 240.9
Cohort 6	830.7	± 333.3

IL-6 pre-dose

Group	Value	95% CI
Cohort 1	1.6	± 0
Cohort 2	1.6	± 0
Cohort 3	1.6	± 0
Cohort 4	1.6	± 0
Cohort 5	1.6	± 0
Cohort 6	7.9	± 10.9

IL-6 4 hour post-dose

Group	Value	95% CI
Cohort 1	1.6	± 0
Cohort 2	1.6	± 0
Cohort 3	38.3	± 51.9
Cohort 4	133.7	± 228.7
Cohort 5	1.6	± 0
Cohort 6	4.7	± 5.3

Tmax (Hr) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8 Secondary · Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4

Tmax: Day 1

Group	Value	95% CI
Cohort 1	2.4	± 0.14
Cohort 2	2.7	± 0.68
Cohort 3	2.6	± 0.27
Cohort 4	2.9	± 0.55
Cohort 5	2.3	± 0.26
Cohort 6	2.2	± 0.14

Tmax: Day 8

Group	Value	95% CI
Cohort 1	2.6	± 0.60
Cohort 2	2.4	± 0.13
Cohort 3	2.7	± 0.35
Cohort 4	2.2	± 0.24
Cohort 5	3.0	± 0.72
Cohort 6	2.2	± 0.24

Cmax_D (kg*ng/mL/mg) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8 Secondary · Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4

Cmax_D: Day 1

Group	Value	95% CI
Cohort 1	16832	± 10192
Cohort 2	23952	± 17701
Cohort 3	20652	± 2482.5
Cohort 4	21794	± 9098.8
Cohort 5	28527	± 12076
Cohort 6	23384	± 4241.4

Cmax_D: Day 8

Group	Value	95% CI
Cohort 1	14045	± 475.74
Cohort 2	27525	± 16827
Cohort 3	22095	± 3852.7
Cohort 4	29964	± 5724.8
Cohort 5	30457	± 20247
Cohort 6	31931	± 10677

AUClast_D (hr*kg*ng/mL/mg) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8 Secondary · Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4

AUClast_D: Day 1

Group	Value	95% CI
Cohort 1	178997	± 125460
Cohort 2	299295	± 312426
Cohort 3	197244	± 116908
Cohort 4	195133	± 56544
Cohort 5	290201	± 169069
Cohort 6	201529	± 45290

AUClast_D: Day 8

Group	Value	95% CI
Cohort 1	163478	± 109924
Cohort 2	739203	± 698459
Cohort 3	389653	± 293467
Cohort 4	350625	± 132910
Cohort 5	274941	± 168548
Cohort 6	383537	± 84286

AUClast (hr*ng/mL) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8 Secondary · Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4

AUClast : Day 1

Group	Value	95% CI
Cohort 1	22375	± 15683
Cohort 2	59859	± 62485
Cohort 3	59173	± 35072
Cohort 4	87810	± 25445
Cohort 5	197337	± 114967
Cohort 6	171299	± 38496

AUClast : Day 8

Group	Value	95% CI
Cohort 1	20435	± 13741
Cohort 2	147841	± 139692
Cohort 3	116896	± 88040
Cohort 4	157781	± 59810
Cohort 5	186960	± 114612
Cohort 6	326006	± 71643

Adverse events — posted to ClinicalTrials.gov

Time frame: Throughout entire duration of the study (e.g., approximately 3 month period). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1

Serious: 1/3 (33%)

Deaths: 2/3

Cohort 2

Serious: 0/3 (0%)

Deaths: 0/3

Cohort 3

Serious: 0/3 (0%)

Deaths: 3/3

Cohort 4

Serious: 1/3 (33%)

Deaths: 1/3

Cohort 5

Serious: 2/6 (33%)

Deaths: 3/6

Cohort 6

Serious: 1/3 (33%)

Deaths: 2/3

Serious adverse events (8 terms)

Reaction	System	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Spinal cord compression/ Spinal Cord Compression Due To Pathologic Fracture Of T1	Nervous system disorders	—	—	—	—	—	—
Oropharyngeal pain/ Sore Throat	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Dyspnoea/ Increased Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Influenza like illness/ Flu Like Symptom	General disorders	—	—	—	—	—	—
Acute coronary syndrome/ Acute Coronary Syndrome	Cardiac disorders	—	—	—	—	—	—
Cholangitis/ Cholangitis Due To Pd	Hepatobiliary disorders	—	—	—	—	—	—
Metastases to bone/ Osteolytic Jaw Lesion Due To Progression Disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Hypovolaemic shock/ Hypovolemic Hypoperfusion	Vascular disorders	—	—	—	—	—	—

Other adverse events (22 terms — click to expand)

Reaction	System	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Cohort 6
Fatigue	General disorders	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
AST increased	Investigations	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—
Influenza-like illness	General disorders	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—
Abdominal distention	Gastrointestinal disorders	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—
ALT increased	Investigations	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—
GGT increased	Investigations	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—

Most-reported serious reactions: Spinal cord compression/ Spinal Cord Compression Due To Pathologic Fracture Of T1, Oropharyngeal pain/ Sore Throat, Dyspnoea/ Increased Dyspnea, Influenza like illness/ Flu Like Symptom, Acute coronary syndrome/ Acute Coronary Syndrome, Cholangitis/ Cholangitis Due To Pd, Metastases to bone/ Osteolytic Jaw Lesion Due To Progression Disease, Hypovolaemic shock/ Hypovolemic Hypoperfusion.

Data from ClinicalTrials.gov NCT02314052 adverse events section.

Sponsor's own description

The purpose of this study is to assess the safety and tolerability of the investigational anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid particle suspension that targets the oncogene MYC. MYC oncogene activation is important to the growth of many hematologic and solid tumor malignancies. In this study the Sponsor proposes to study DCR-MYC and its ability to inhibit MYC and thereby inhibit cancer cell growth.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Nanoparticles in the clinic: An update.
Anselmo AC, Mitragotri S. · · 2019 · cited 976× · PMID 31572799 · DOI 10.1002/btm2.10143
Nanoparticles in the clinic.
Anselmo AC, Mitragotri S. · · 2016 · cited 773× · PMID 29313004 · DOI 10.1002/btm2.10003
Smart nanoparticles for cancer therapy.
Sun L, Liu H, Ye Y, Lei Y, et al · · 2023 · cited 474× · PMID 37919282 · DOI 10.1038/s41392-023-01642-x
Advances in the delivery of RNA therapeutics: from concept to clinical reality.
Kaczmarek JC, Kowalski PS, Anderson DG. · · 2017 · cited 467× · PMID 28655327 · DOI 10.1186/s13073-017-0450-0
Lipids and Lipid Derivatives for RNA Delivery.
Zhang Y, Sun C, Wang C, Jankovic KE, et al · · 2021 · cited 423× · PMID 34279087 · DOI 10.1021/acs.chemrev.1c00244
Preclinical and clinical development of siRNA-based therapeutics.
Ozcan G, Ozpolat B, Coleman RL, Sood AK, et al · · 2015 · cited 331× · PMID 25666164 · DOI 10.1016/j.addr.2015.01.007
Lipid-Based Nanoparticles in the Clinic and Clinical Trials: From Cancer Nanomedicine to COVID-19 Vaccines.
Thi TTH, Suys EJA, Lee JS, Nguyen DH, et al · · 2021 · cited 317× · PMID 33918072 · DOI 10.3390/vaccines9040359
Therapeutic siRNA: State-of-the-Art and Future Perspectives.
Friedrich M, Aigner A. · · 2022 · cited 256× · PMID 35997897 · DOI 10.1007/s40259-022-00549-3

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02314052 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Last refreshed: 11 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02314052.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02314052

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (8 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Hepatocellular Carcinoma

Other Dicerna Pharmaceuticals, Inc., a Novo Nordisk company trials

Verify against primary sources