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NCT02992483
Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma
Phase 1 trial testing MIK665 in Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma in 31 participants. Completed in 7 June 2019.
7 June 2019
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 12 July 2017 |
| Primary completion | 7 June 2019 |
| Estimated completion | 7 June 2019 |
| Sites | 8 locations across France, Italy, Japan, Germany, Australia, United States, Spain |
Drugs / interventions tested
- MIK665 — full drug profile →
Conditions studied
- Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma — all drugs for Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this first in human study is to assess safety, tolerability, PK and preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred as S64315) as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed lymphoma or multiple myeloma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting apoptosis in cancer therapy.
Carneiro BA, El-Deiry WS. · · 2020 · cited 1823× · PMID 32203277 · DOI 10.1038/s41571-020-0341-y -
Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.
Zhong L, Li Y, Xiong L, Wang W, et al · · 2021 · cited 1003× · PMID 34054126 · DOI 10.1038/s41392-021-00572-w -
Targeting BCL-2 regulated apoptosis in cancer.
Campbell KJ, Tait SWG. · · 2018 · cited 352× · PMID 29769323 · DOI 10.1098/rsob.180002 -
Apoptosis: A Comprehensive Overview of Signaling Pathways, Morphological Changes, and Physiological Significance and Therapeutic Implications.
Mustafa M, Ahmad R, Tantry IQ, Ahmad W, et al · · 2024 · cited 264× · PMID 39594587 · DOI 10.3390/cells13221838 -
Mitochondria-associated programmed cell death as a therapeutic target for age-related disease.
Nguyen TT, Wei S, Nguyen TH, Jo Y, et al · · 2023 · cited 221× · PMID 37612409 · DOI 10.1038/s12276-023-01046-5 -
Targeting MCL-1 in cancer: current status and perspectives.
Wang H, Guo M, Wei H, Chen Y. · · 2021 · cited 210× · PMID 33883020 · DOI 10.1186/s13045-021-01079-1 -
Targeting MCL-1 in hematologic malignancies: Rationale and progress.
Wei AH, Roberts AW, Spencer A, Rosenberg AS, et al · · 2020 · cited 157× · PMID 32204955 · DOI 10.1016/j.blre.2020.100672 -
Recent advances in targeted therapies in acute myeloid leukemia.
Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
Verify or expand the search:
- PubMed search for NCT02992483
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MIK665
Trials testing the same drug.
- NCT04702425 — VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodg · Phase 1 · terminated
Other recruiting trials for Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
Currently open trials in the same condition.
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- NCT07309497 — Pragmatic Geriatric Assessment Before CAR-T or Bispecific Antibody Therapy to Predict Side Effects and Outcomes in Older · recruiting
- NCT07305337 — Randomised Controlled Trial of Artificial Intelligence-assisted Health Education · NA · recruiting
- NCT07270263 — Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies · NA · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02992483 (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 Novartis Pharmaceuticals
- Last refreshed: 3 August 2021
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/NCT02992483.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing