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Topoisomerase I inhibitor

Irinotecan Hydrochloride for Colon Cancer

Phase 1

Waitlist Available

Led By Patricia M LoRusso

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of veliparib when given with irinotecan hydrochloride to treat patients with cancer.

Eligible Conditions

Colon Cancer
Solid Tumors
Pancreatic Cancer
Breast Cancer
Lung Cancer
Cancer
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Malignant Tumor
Ovarian Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at days 1, 2, and 3 of course 1 and days 1, 8, 9, and 10 of course 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximally tolerated dose (MTD) of study drugs

Maximum administered dose of study drugs

Optimal biologic dose (OBD)

+1 more

Secondary outcome measures

Incidence of adverse events (AEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Tumor response

Other outcome measures

Change in gamma-H2AX foci and/or Rad51 levels

Change in poly(ADP-ribose) polymerase (PARP) levels in peripheral blood mononuclear cells (PBMCs)

Circulating tumor cell (CTC) counts

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Intermittent dose escalation (irinotecan, ABT-888)Experimental Treatment4 Interventions

Patients receive irinotecan hydrochloride IV over 90 minutes on days 3 and 10 and veliparib PO BID on days 1 to 4 and 8-11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Expansion portion (irinotecan hydrochloride and veliparib)Experimental Treatment4 Interventions

Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and veliparib PO BID on days 1-15 (days 2-15 of course 1 only). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group III: Dose escalation (irinotecan hydrochloride and veliparib)Experimental Treatment4 Interventions

Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and veliparib PO BID on days -1 to 14 (days 3-14 of course 1 only). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan Hydrochloride

2010

Completed Phase 3

~1940

Veliparib

2012

Completed Phase 3

~4820

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,117 Total Patients Enrolled

Patricia M LoRussoPrincipal InvestigatorYale University Cancer Center LAO

5 Previous Clinical Trials

306 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What disorders are generally targeted with Pharmacological Study?

"Pharmacological Study is frequently prescribed to treat aggressive cancer of the pancreas and can also be used in combination with other therapies to address metastatic neoplasms, gastric cancers, and rhabdomyosarcomas."

Answered by AI

Are there additional investigations into Pharmacological Study?

"Presently, there are 280 active studies on Pharmacological Study with 55 of them in phase 3. These trials have been conducted across 11226 sites worldwide; the most significant presence is located in Woolloongabba, Queensland."

Answered by AI

How many facilities are currently engaging in this clinical trial?

"This interventional study is welcoming participants from Dana-Farber Cancer Institute in Boston, Wayne State University/Karmanos Cancer Institute in Detroit and the University of Maryland/Greenebaum Cancer Center located in Baltimore as well as five additional medical centres."

Answered by AI

Could you provide an assessment of the potential risks associated with Pharmacological Study for participants?

"Our team gave this pharmacological study a score of 1, as there is only limited clinical data supporting its safety and efficacy at the moment."

Answered by AI

Is the enrollment process for this research still open?

"This experiment has concluded its patient recruitment. It started recruiting on December 5th 2007 and ended advertising for participants on July 27 2022. If you are in search of other medical studies, there are currently 8595 clinical trials looking for individuals with pancreatic cancer and 280 drug-related experiments open to enrolment."

Answered by AI

To what extent is participation being sought for this research?

"At the present time, this clinical trial is not accepting new patients. The listing was initially posted on December 5th 2007 and revised lastly on July 27th 2022. For those searching for alternate studies, 8595 trials involving cancer of the pancreas are recruiting participants while 280 medical studies related to pharmacology are currently enrolling individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Veliparib and Irinotecan Hydrochloride in Treating Patients With Cancer That Is Metastatic or Cannot Be Removed by Surgery

2007. "Veliparib and Irinotecan Hydrochloride in Treating Patients With Cancer That Is Metastatic or Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00576654.