Metformin in Children With Relapsed or Refractory Solid Tumors

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the tolerability and safety of escalating doses of metformin on a backbone of vincristine, irinotecan and temozolomide (VIT) in children with recurrent and refractory solid tumors.

Clinical Trial Description

Metformin is an oral anti-diabetes medication that activates AMP-activated protein kinase (AMPK). Recent data from in vitro and in vivo experiments, as well as epidemiologic retrospective analyses, suggest that metformin has anti-cancer activity. Vincristine, irinotecan, and temozolomide (VIT) is a combination of chemotherapeutic agents that have different mechanisms of action as well as disparate side effect profiles. Two recent phase 1 trials have demonstrated that this regimen is safe and well-tolerated in children with relapsed and refractory solid tumors. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01528046
Study type	Interventional
Source	H. Lee Moffitt Cancer Center and Research Institute
Contact
Status	Completed
Phase	Phase 1
Start date	September 24, 2012
Completion date	February 3, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT00750841` - Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours	Phase 1
Withdrawn	`NCT05419817` - Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System	Phase 2
Completed	`NCT02828930` - A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies)	Phase 1
Completed	`NCT01197170` - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance	Phase 1
Terminated	`NCT03225105` - M3541 in Combination With Radiotherapy in Solid Tumors	Phase 1
Completed	`NCT03258515` - A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers	Phase 1
Completed	`NCT01497925` - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer	Phase 1
Completed	`NCT01878890` - Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.	Phase 1
Active, not recruiting	`NCT05059522` - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing	Phase 3
Active, not recruiting	`NCT03634982` - Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors	Phase 1
Recruiting	`NCT04685226` - A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Recruiting	`NCT06036121` - A Study of ADRX-0706 in Select Advanced Solid Tumors	Phase 1
Active, not recruiting	`NCT03258151` - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Recruiting	`NCT05325866` - A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression	Phase 1/Phase 2
Recruiting	`NCT04557449` - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors	Phase 1/Phase 2
Completed	`NCT02759640` - A Phase I Trial of HS-10241 in Solid Tumors	Phase 1
Terminated	`NCT02890368` - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides	Phase 1
Withdrawn	`NCT01940601` - Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors	Phase 2
Completed	`NCT02279433` - A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b	Phase 1