Dose escalation of indibulin given twice daily for up to 6 months

indibulin

Jonathan Lewis, MD

Dose escalating study of orally administered indibulin at twice daily schedule in subjects with solid tumors.

Phase I Study in Advanced Solid Tumors

IBL1002:Phase I Study of Indibulin in Advanced Solid Tumors

Alaunos Therapeutics

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Indibulin given orally once a day for 5 days followed by a 9 day rest

Indibulin

Jonathan J. Lewis, MD, PhD

This study is a Phase I/II trial of a novel Indibulin dosing schedule for the treatment of metastatic breast cancer. Eligible patients will have measurable or non-measurable, metastatic or unresectable, locally advanced breast cancer and may have received any number of prior therapies for their disease.

It is expected that the Phase I portion will enroll up to 20 patients and the Phase II portion will enroll up to 45 patients.

Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer

Phase I/II Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer

The primary objective of the Phase I portion of the trial is to determine the maximum tolerated dose (MTD) of Indibulin when given for 5 days followed by a 9 day rest (5-9) using a standard 3+3 dose escalation scheme for the treatment of metastatic breast cancer

The primary objective of the Phase II portion of this trial is to examine the efficacy of indibulin for the treatment of metastatic breast cancer at the MTD established in Phase I. The primary endpoint is the proportion of patients who are progression free at 4 months when treated with Indibulin (5-9)at the MTD determined by the phase I portion of the trial.

To evaluate the safety of Indibulin when administered for 5 days followed by a 9 day rest (5-9) in patients with metastatic breast cancer

To describe the Cycle I and overall toxicity rates of indibulin (5-9) using the NCI CTC version 3.

To evaluate pharmacokinetics (PK) of Indibulin (5-9) as it is assessed in Cycle 1 Day 1, Day 2, Day 5 and Day 8. Cycle 1 PK schedule as follows: Day 1 immediately pre dose, 1 hour, 2 hours, 4 hours, 6 hours and approximately 24 hours after start of infusion (Cycle 2 Day 1), Day 5 pre-dose and at anytime during Day 8.

To estimate the overall response rate (complete response and partial response)associated with Indibulin (5-9) schedule at eth MTD determined by the Phase I portion of this trial in patients with metastatic breast cancer.

To estimate the rate of stable disease greater than 6 months associated with the Indibulin (5-9) schedule at the MTD determined by the the Phase I portion of this trial in patients with metastatic breast cancer.

To evaluate the safety of Indibulin when administered for 5 days followed by a 9 day rest (5-9) at the MTD determined by the Phase I portion of this trial in patients with metastatic breast cancer.

Memorial Sloan Kettering Cancer Center

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Once Maximum Tolerated Dose (MTD) is determined an expanded cohort will be enrolled to evaluate efficacy.

indibulin, dose escalation, 200 mg - 600 mg. Taken twice every day.

erlotinib taken at 150 mg every morning with food.

erlotinib

Single arm, open label, Phase I, dose-escalation study of indibulin in combination with erlotinib in subjects with advanced histologically confirmed, solid tumors for which no standard therapy exists and for whom treatment with erlotinib is considered medically acceptable.

Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors

dose escalation of indibulin given twice daily for 21 days, to be repeated every 28 days.

Single arm, open label, Phase IB study of indibulin capsules in subjects with advanced solid tumors; eligible subjects will have a baseline PET scan showing a standardized uptake value (SUV) of ≥5.0 in ≥1 lesion on an 18F-FDG (fluorine-18-labeled deoxyglucose) scale.

Phase IB Study of Indibulin Using Positron-Emission Tomography (PET) Scans

Phase IB Study to Evaluate the Biological Activity of Indibulin Using Positron-Emission Tomography (PET) Scans

Capecitabine

Antimetabolites

Single arm designed to elicit Maximum Tolerated Dose

indibulin, dose escalation, 400-600 mg taken twice every day

capecitabine, dose escalation, 875 mg/m2- 1250 mg/m2, taken twice daily for 14 days per 21 day cycle

capecitabine

This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors.

The primary objective of the trial is to determine the maximum tolerated dose (MTD) and optimal dosing schedule of indibulin in combination with capecitabine in subjects diagnosed as having advanced solid tumors.

Secondary objectives include the determination of dose-limiting toxicity (DLT), safety and tolerability, and preliminary activity of this combination. In addition, biological activity of indibulin in combination with capecitabine will be evaluated.

Single arm, open label, Phase Ib, dose-escalation study of indibulin in combination with capecitabine in subjects with advanced histologically confirmed, solid tumors for which no standard therapy exists and for whom treatment with capecitabine is considered medically acceptable.

3 subjects will be treated at each dose level. When DLT occurs in 2 or more of 6 or fewer subjects, MAD has been reached and the dose will be reduced to the previous dosing level, which will be considered the MTD.

Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors

Dose escalation, daily dosing for 14 days every 3 weeks, for up to 4 months

Jonathan Lewis, MD, PhD

Dose-finding and pharmacokinetic trial of orally administered Indibulin to patients with solid tumors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Study in Advanced Solid Tumors	NCT00591292	Solid Tumors	indibulin	18 Years -	Alaunos Therapeutics
Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer	NCT01113970	Metastatic Brea...	Indibulin	18 Years -	Alaunos Therapeutics
Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors	NCT00591383	Advanced Solid ...	indibulin erlotinib	18 Years -	Alaunos Therapeutics
Phase IB Study of Indibulin Using Positron-Emission Tomography (PET) Scans	NCT00591890	Advanced Cancer	indibulin	18 Years -	Alaunos Therapeutics
Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors	NCT00726687	Advanced Solid ...	indibulin capecitabine	18 Years -	Alaunos Therapeutics
Phase I Study of Indibulin in Patients With Solid Tumors	NCT00591136	Solid Tumors	indibulin	18 Years -	Alaunos Therapeutics
Phase I Study of Indibulin in Patients With Solid Tumors	NCT00591136	Solid Tumors	indibulin	18 Years -	Alaunos Therapeutics
Phase IB Study of Indibulin Using Positron-Emission Tomography (PET) Scans	NCT00591890	Advanced Cancer	indibulin	18 Years -	Alaunos Therapeutics

Spots Global Cancer Trial Database for indibulin

Every month we try and update this database with for indibulin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for indibulin

Every month we try and update this database with for indibulin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for indibulin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.