Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT02900651
• Date of registration: 02/09/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies
• Scientific title: A Phase I/II, Multicenter, Open-label Study of MAK683 in Adult Patients With Advanced Malignancies
• Date of first enrolment: October 3, 2016
• Target sample size: 139
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02900651
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Canada, China, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Singapore, Spain, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG): 0 to 2

2. Relapsed or refractory diffuse large B cell lymphoma with measurable disease as
determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)

3. Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma,
castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and
sarcoma, with measurable disease as determined by RECIST 1.1.

Exclusion Criteria:

1. Other malignant diseases than the ones being treated in this study

2. Severe and/or uncontrolled medical conditions that in the investigator's opinion could
affect the safety of individual or impair the assessment of study result.

3. B-cell lymphoma patients who have received prior allogeneic stem cell transplant

4. Patient have received anti-cancer therapies within defined time frames prior to the
first dose of study treatment

5. Symptomatic central nervous system (CNS) involvement which are neurologically unstable
or requiring increasing doses of steroids to control.

6. Patient having out of range laboratory values defined as:

1) Insufficient bone marrow function at screening:

- Platelets = 50,000/mm3

- Hemoglobin (Hgb) = 80 g/L

- Absolute neutrophil count (ANC) = 1000/mm3 2) Insufficient hepatic and renal function
at screening:

- ALP, ALT, and AST > 3 x ULN (>5 x ULN if subject has liver metastases)

- Total bilirubin >1.5 x ULN

- Serum creatinine > 1.5 x ULN and/or creatinine clearance = 50 mL/min



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diffuse Large B-cell Lymphoma

Intervention(s)

Drug: MAK683

Primary Outcome(s)

Incidence of dose limiting toxicities (DLTs) [Time Frame: up to 28 days]

Safety and tolerability [Time Frame: up to approximately 3 years]

Secondary Outcome(s)

Duration of overall response (DOR) [Time Frame: up to 30 months]

Progression-free survival (PFS) [Time Frame: up to 30 months]

Area Under the Plasma Concentration (AUC) Time Curve of MAK683 [Time Frame: 30 months]

Best Overall Response (BOR) [Time Frame: up to 30 months]

Peak Plasma Concentration (Cmax) of MAK683 [Time Frame: 30 months]

Half-Life of MAK683 [Time Frame: 30 months]

Overall Response Rate (ORR) [Time Frame: up to 30 months]

H3K27 tri methylation level in PBMC [Time Frame: up to day 15]

Secondary ID(s)

2016-001860-12

CMAK683X2101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors