NCT02867618

Carfilzomib and TGR-1202 in Treatment of R/R Lymphoma

Terminated Phase 1, PHASE2 Results posted Last updated 16 July 2021

What this trial tests

Phase 1, PHASE2 trial testing Carfilzomib in Hodgkin Disease in 14 participants. Terminated before completion.

Timeline

16 October 2016

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Columbia University
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	16 October 2016
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Carfilzomib (carfilzomib) — full drug profile →
• TGR-1202 — full drug profile →

Conditions studied

• Hodgkin Disease — all drugs for Hodgkin Disease →
• Lymphoma, Non-hodgkin — all drugs for Lymphoma, Non-hodgkin →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Hodgkin Disease or Lymphoma, Non-hodgkin. 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.

Maximum Tolerated Dose (MTD) (Phase 1) - TGR-1202 Only Primary · 9 months

The highest dose of the study treatment that does not cause unacceptable side effects.

Group	Value	95% CI
Carfilzomib + TGR-1202	800

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 1 year post study treatment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Carfilzomib + TGR-1202

Serious: 1/11 (9%)

Deaths: 1/11

Serious adverse events (1 terms)

Reaction	System	Carfilzomib + TGR-1202
Neutropenia	Blood and lymphatic system disorders	—

Most-reported serious reactions: Neutropenia.

Data from ClinicalTrials.gov NCT02867618 adverse events section.

Sponsor's own description

This is an open label, phase I/II, dose-escalation study in the initial phase I followed by a phase II.

The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of TGR-1202 and carfilzomib in participants with relapsed and refractory (R/R) non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). The safety and toxicity of this combination will be evaluated throughout the entire study.

If the combination of TGR-1202 and carfilzomib is found to be feasible and an MTD is established, the phase II part of the study will be initiated.

Phase II will consist of a 2-stage design of the combination of TGR-1202 and carfilzomib for participants with R/R NHL.

Publications & conference data

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

1. Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
   Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
2. Advances in targeted therapy for malignant lymphoma.
   Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
3. Silencing c-Myc translation as a therapeutic strategy through targeting PI3Kδ and CK1ε in hematological malignancies.
   Deng C, Lipstein MR, Scotto L, Jirau Serrano XO, et al · · 2017 · cited 83× · PMID 27784673 · DOI 10.1182/blood-2016-08-731240
4. PI3Kδ-selective and PI3Kα/δ-combinatorial inhibitors in clinical development for B-cell non-Hodgkin lymphoma.
   Lampson BL, Brown JR. · · 2017 · cited 61× · PMID 28945111 · DOI 10.1080/13543784.2017.1384815
5. Repurposing anticancer drugs for the management of COVID-19.
   El Bairi K, Trapani D, Petrillo A, Le Page C, et al · · 2020 · cited 59× · PMID 33125946 · DOI 10.1016/j.ejca.2020.09.014
6. Unlocking the NF-κB Conundrum: Embracing Complexity to Achieve Specificity.
   Begalli F, Bennett J, Capece D, Verzella D, et al · · 2017 · cited 51× · PMID 28829404 · DOI 10.3390/biomedicines5030050
7. Dysregulation of Cell Survival in Diffuse Large B Cell Lymphoma: Mechanisms and Therapeutic Targets.
   Miao Y, Medeiros LJ, Xu-Monette ZY, Li J, et al · · 2019 · cited 39× · PMID 30881917 · DOI 10.3389/fonc.2019.00107
8. NFkB Pathway and Hodgkin Lymphoma.
   Jardin F. · · 2022 · cited 26× · PMID 36140254 · DOI 10.3390/biomedicines10092153