A safety and efficacy study of MAK683 in adults patients with advanced solid tumors

Phase 1

• Conditions: Advanced malignancies; MedDRA version: 19.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; MedDRA version: 19.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001860-12-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-08
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1.Patients Age > = 18 years
[For Japan only: written consent is necessary from both the patient and his /her legal representative if he/she is under the age of 20 years.]
2.ECOG performance status 0 to 2
3.Patients with relapsed or refractory diffuse large B cell lymphoma, follicular lymphoma, other B cell lymphoma with measurable disease as determined by Non-Hodgkin’s Lymphoma Cheson response criteria (2014)
4.Patients with advanced solid tumor, including Nasopharyngeal carcinoma (Phase II part- Nasopharyngeal carcinoma patients without homozygous p16-deletion and other indications supported by emerging data, with measurable disease as determined by RECIST 1.1.
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

1.Other malignant disease than the one 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 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 x 109/L (50,000/mm3)
•Hemoglobin (Hgb) < = 90 g/L (9 g/dL)
•Absolute neutrophil count (ANC) < = 1.0 x 109/L (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 > =2 x ULN
•Serum creatinine > 1.5 x ULN and/or creatinine clearance < = 50 mL/min
7.Unable to stop any prohibited medications, including strong CYP3A4 inhibitors or inducers, CYP3A4 or CYP2C8 substrates with a narrow therapeutic index, long acting proton pump inhibitors.
Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified