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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
Patients enrolled on the dose escalation for intermittent ABT-888 portion of the study must histologically or cytologically confirmed diagnosis of malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or for whom CPT-11 treatment would be a viable therapy regimen; patients with solid hematologic malignancies (Hodgkin's and non-Hodgkin's lymphomas) may be included as long as a bone marrow has been performed within 6 weeks of treatment
Life expectancy of greater than 12 weeks
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a cancer that has spread and cannot be treated with standard methods. You may be eligible if you have solid tumors or certain types of blood cancer, but your bone marrow needs to be tested within 6 weeks before treatment.
Select...
You are expected to live for at least 12 more weeks.

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
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

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
~2 spots leftby Apr 2025