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Alkylating Agent

Veliparib + Chemotherapy for Advanced Cancer

Phase 1
Waitlist Available
Led By Hussein A Tawbi
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 must have histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, for which standard curative or palliative measures do not exist or are no longer effective, and for which there is expectation of response to the combination of carboplatin/paclitaxel
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -6 and 3 of course 1 after veliparib dosing
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of veliparib when given with paclitaxel and carboplatin to treat patients with solid tumors that have spread or cannot be removed by surgery and have liver or kidney dysfunction.

Who is the study for?
This trial is for patients with various types of advanced solid tumors that have spread or can't be surgically removed, and who also have liver or kidney dysfunction. They must not have had certain treatments before, should not be pregnant or breastfeeding, and need to use birth control. People with severe allergies to similar drugs, uncontrolled illnesses, a history of seizures, recent chemotherapy/radiotherapy, or HIV on specific therapies cannot join.Check my eligibility
What is being tested?
The study is testing the combination of Veliparib with Paclitaxel and Carboplatin in patients with metastatic solid tumors and organ dysfunction. It aims to find the safest dose that can effectively kill tumor cells by blocking enzymes needed for cell growth while stopping them from dividing or spreading.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system suppression such as infection risk increase; blood-related issues like anemia; nerve damage which could cause tingling sensations; allergic reactions; gastrointestinal symptoms like nausea; fatigue due to treatment intensity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -6 and 3 of course 1 after veliparib dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -6 and 3 of course 1 after veliparib dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD of veliparib in combination with carboplatin and paclitaxel, determined according to incidence of DLT as graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0
PK parameters of veliparib
Secondary outcome measures
Incidence of stable disease as assessed by RECIST version 1.1
Incidence of toxicities as assessed by NCI CTCAE v4.0
Response rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
+1 more
Other outcome measures
Change in PAR levels
Body Weight Changes

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (veliparib, paclitaxel, carboplatin)Experimental Treatment5 Interventions
Patients receive veliparib* PO BID on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 3. Courses repeat every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. NOTE: * All patients receive a single dose of veliparib PO on day -6 before course 1 (except patients with very severe renal dysfunction who receive veliparib on day -5 or -6 to coincide with a dialysis day).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Veliparib
2012
Completed Phase 3
~4820
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,059 Total Patients Enrolled
3 Trials studying Kidney Failure
53 Patients Enrolled for Kidney Failure
AbbottIndustry Sponsor
750 Previous Clinical Trials
478,206 Total Patients Enrolled
1 Trials studying Kidney Failure
64 Patients Enrolled for Kidney Failure
Hussein A TawbiPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute (UPCI)
4 Previous Clinical Trials
389 Total Patients Enrolled

Media Library

Carboplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01366144 — Phase 1
Kidney Failure Research Study Groups: Treatment (veliparib, paclitaxel, carboplatin)
Kidney Failure Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01366144 — Phase 1
Carboplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01366144 — Phase 1

Frequently Asked Questions

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

How many test subjects are participating in this clinical experiment?

"This particular medical study is not accepting participants at this time. The original posting was dated June 20th 2011, and the last update happened on July 27th 2022. If you are looking for alternate trials, there are 8049 studies with liver failure as their primary focus and 1187 related to Veliparib that currently have open admission criteria."

Answered by AI

Are any facilities in North America currently conducting this trial?

"The University of Wisconsin Hospital and Clinics, Wayne State University/Karmanos Cancer Institute, and M D Anderson Cancer Center are just 3 out of the 21 locations that this trial is being conducted at. Detroit in Michigan, Houston in Texas and Atlanta in Georgia are some major cities where it can be accessed."

Answered by AI

Are there any further investigations that have been done with Veliparib?

"The City of Hope Comprehensive Cancer Center pioneered the study of veliparib in 1997, and since then a total of 2123 trials have been completed. Currently 1187 studies are active with many conducted out from Detroit, Michigan."

Answered by AI

What medical conditions can Veliparib be employed to treat?

"Veliparib has the capacity to mitigate melanoma, neoplasm metastasis, and non-Hodgkin's Lymphoma."

Answered by AI

To what extent is Veliparib a safe treatment option for individuals?

"Our team at Power assessed Veliparib's safety on a scale from 1 to 3, rating it as 1 due to its Phase 1 status, which means that there is limited evidence in support of efficacy and safety."

Answered by AI

Is the research team still in search of participants for this trial?

"At this time, recruitment for the mentioned trial has been suspended. This research was posted on June 20th 2011 and most recently updated on July 27th 2022. For those seeking alternative medical trials, 8049 studies recruiting patients with liver failure are ongoing as well as 1187 trials for Veliparib that require patient enrollment."

Answered by AI

What objectives does this research endeavor seek to accomplish?

"The primary goal of this trial is to identify the maximum tolerated dose (MTD) of veliparib in combination with carboplatin and paclitaxel. This will be quantified using the NCI Common Terminology Criteria for Adverse Events v4.0 across Days -6 to 3 of Course 1 after dosing begins. Secondary objectives include measuring incidence of stable disease, response rate, and time to progression; all according to RECIST version 1.1 criteria."

Answered by AI

Who else is applying?

What site did they apply to?
Emory University Hospital/Winship Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction
2011. "Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01366144.
All > Acl > Endometrial Cancer
~7 spots leftby Apr 2025
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