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Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors | Clinical Trials | Clareo Health

SUSPENDEDPHASE1

Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors

An Open Label Multicentre Phase 1 Study of Oral IGF-1R Inhibitor PL225B in Subjects With Advanced Refractory Solid Tumors.

NCT01779336•Piramal Enterprises Limited

View on ClinicalTrials.gov

Summary

Clinical study of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity (ies) of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid tumors.

Detailed Description

An open label multicentre Phase 1 study of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid tumors. This is a dose-finding trial using the modified Accelerated Titration Design with 3 new subjects per cohort and 100% dose increments in the accelerated phase followed by standard phase with 40% dose increments.Subjects will receive study drug on a daily basis for twenty-one (21) days according to the dose and schedule specified for a particular cohort of therapy. Toxicity profile of the drug will be assessed during Cycle 1 of subject treatment in each cohort for determination of Maximum Tolerated Dose (MTD) according to the schedule given below.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects having histologically and/or cytologically confirmed non-haematological malignancy that is metastatic or unresectable and for which standard curative or palliative treatment does not exist or is no longer effective
•Subjects should have measurable or evaluable disease
•Subjects of either sex, of all races and ethnic groups, and ≥18 years of age
•ECOG (Eastern Cooperative Oncology Group) performance status 0-1
•Subjects with life expectancy of at least 4 months
•Subjects with fasting plasma glucose ≤ 125 mg/dL and HbA1c \< 6.5 % at screening Subjects with fasting plasma glucose ≤150 mg/dL and HbA1c ≤ 7.0 % at screening for the Diabetes Expansion Cohort.
•For the Diabetes Expansion Cohort - Subjects with known history of type 2 diabetes mellitus that are well-controlled on a stable dose of oral anti-diabetic agents such as metformin and/or sulfonylureas for 4 weeks prior to screening.
•Subjects must have normal organ and marrow function as defined below:
•1. Absolute neutrophil count ≥ 1500/cmm
•2. Platelets ≥ 100,000/cmm
+6 more criteria

Exclusion Criteria

•Subjects who have received any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy or surgery within 4 weeks (6 weeks for monoclonal antibodies, radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before the first study drug administration and have not recovered (to AEs \< Grade 2) from the toxic effects from any prior therapy
•Subjects having received any other investigational agents within 4 weeks prior to the first study drug administration and have not recovered completely (to AEs \< Grade 2) from the side effects of the earlier investigational agent
•Subjects with documented history of diabetes mellitus except for the Diabetes Expansion Cohort
•For the Diabetes Expansion Cohort - Subjects who have type 1 diabetes mellitus, maturity onset diabetes of the young, hyperglycemia due to reasons other than type 2 diabetes mellitus.
•For the Diabetes Expansion Cohort - Subjects who currently require insulin, thiazolidinediones, dual proliferator-activated receptors (PPAR) agonists, glucagon-like peptide (GLP-1) analogues, dipeptidyl peptidase (DPP-IV) inhibitors or have received the same in the 4 weeks prior to screening.
•Subjects with known complications of diabetes like diabetic nephropathy or diabetic retinopathy
•Subjects with known brain metastases
•Subjects with gastrointestinal abnormalities including inability to take oral medication, malabsorption or other conditions like chronic inflammatory bowel disease that may affect absorption.
•Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months
•Subjects with baseline QTc interval \>470 msec at screening
+5 more criteria

Locations (5)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Central India Cancer Research Institute

Nagpur, Maharashtra, India

Curie Manavata Cancer Centre

Nashik, Maharashtra, India

Ruby Hall Clinic

Pune, Maharashtra, India

Meenakshi Mission Hospital and Research Centre

Madurai, Tamil Nadu, India

Key Dates

Start Date

December 1, 2012

Primary Completion Date

November 1, 2014

Completion Date

December 1, 2014

Last Updated

September 29, 2014

Enrollment

ESTIMATED participants

Conditions

Advanced Refractory Solid Tumors

Interventions

PL225B

DRUG

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TERMINATEDPHASE1

Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

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COMPLETEDPHASE1

An Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors

Inclusion Criteria

Exclusion Criteria

Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors

Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

An Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0)

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors