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Topoisomerase I inhibitor

Liposomal Irinotecan + Veliparib for Cancer

Phase 1
Waitlist Available
Led By Susan Bates
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 pathologically confirmed diagnosis of a solid tumor cancer for which there is no known standard therapy capable of extending life expectancy
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 28 days
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of two drugs, veliparib and liposomal irinotecan, when given together to patients with solid tumors. These drugs may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?
Adults with solid tumor cancers lacking life-extending standard therapies can join this trial. Prior PARP inhibitor therapy is okay, except for ovarian cancer patients with a BRCA mutation who must have had olaparib. Participants need normal bilirubin levels, acceptable blood counts, and organ function; they should not be pregnant or breastfeeding and must agree to use contraception. Excluded are those with recent chemo/radiotherapy, severe allergies to similar drugs, HIV on antiretrovirals, symptomatic brain metastases, interstitial lung disease, GI disorders preventing pill swallowing.Check my eligibility
What is being tested?
The trial tests the combination of liposomal irinotecan and veliparib for treating solid tumors by blocking enzymes that promote cell growth. It aims to determine the safest doses while monitoring side effects using MRI scans and biomarker analysis in participants without standard treatment options.See study design
What are the potential side effects?
Potential side effects include allergic reactions to drug components (especially if there's a history of multiple drug allergies), gastrointestinal issues like bowel obstruction history unless surgically treated long ago, risk of seizures especially in those with seizure disorders or recent seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed and has no treatment known to extend life.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My white blood cell count is healthy without needing medication to boost it.
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My kidney function, measured by creatinine or clearance, is within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum tolerated dose and recommended phase II dose of liposomal irinotecan in combination with veliparib
Secondary outcome measures
Clinical benefit rate defined as complete response, partial response, or stable disease
Objective response rate
Progression free survival
+1 more
Other outcome measures
Biomarker levels

Side effects data

From 2024 Phase 3 trial • 509 Patients • NCT02163694
87%
NEUTROPENIA
76%
THROMBOCYTOPENIA
76%
ANAEMIA
71%
NAUSEA
54%
ALOPECIA
50%
FATIGUE
46%
PERIPHERAL SENSORY NEUROPATHY
45%
DIARRHOEA
40%
LEUKOPENIA
36%
HEADACHE
34%
CONSTIPATION
34%
VOMITING
25%
ASTHENIA
24%
DECREASED APPETITE
24%
HYPOMAGNESAEMIA
21%
COUGH
20%
DYSPNOEA
20%
PAIN IN EXTREMITY
20%
DYSGEUSIA
19%
DIZZINESS
19%
OEDEMA PERIPHERAL
18%
BACK PAIN
18%
DYSPEPSIA
18%
INSOMNIA
18%
ARTHRALGIA
18%
EPISTAXIS
17%
MYALGIA
17%
DRUG HYPERSENSITIVITY
16%
ABDOMINAL PAIN UPPER
16%
PYREXIA
16%
NASOPHARYNGITIS
16%
ALANINE AMINOTRANSFERASE INCREASED
14%
ABDOMINAL PAIN
14%
UPPER RESPIRATORY TRACT INFECTION
14%
ASPARTATE AMINOTRANSFERASE INCREASED
13%
LYMPHOPENIA
13%
STOMATITIS
12%
HYPOKALAEMIA
12%
URINARY TRACT INFECTION
12%
BONE PAIN
11%
ANXIETY
11%
RASH
11%
HOT FLUSH
10%
DRY MOUTH
9%
PRURITUS
9%
HYPOCALCAEMIA
9%
PARAESTHESIA
9%
DEPRESSION
9%
MUCOSAL INFLAMMATION
8%
HYPOPHOSPHATAEMIA
8%
OROPHARYNGEAL PAIN
7%
MUSCULOSKELETAL CHEST PAIN
7%
DRY SKIN
7%
INFLUENZA LIKE ILLNESS
7%
VERTIGO
7%
SINUSITIS
7%
MUSCULOSKELETAL PAIN
7%
DRY EYE
7%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
LYMPHOEDEMA
6%
RHINORRHOEA
6%
PALPITATIONS
6%
DYSPNOEA EXERTIONAL
6%
TINNITUS
6%
WEIGHT INCREASED
6%
HYPERTENSION
6%
HYPERGLYCAEMIA
6%
NEUROPATHY PERIPHERAL
6%
TOOTHACHE
6%
PAIN
5%
CHEST PAIN
5%
DEHYDRATION
5%
GASTROOESOPHAGEAL REFLUX DISEASE
5%
BREAST PAIN
5%
HYPONATRAEMIA
5%
PRODUCTIVE COUGH
5%
ERYTHEMA
5%
MUSCLE SPASMS
5%
ABDOMINAL DISTENSION
5%
INFLUENZA
5%
RHINITIS
4%
MALIGNANT NEOPLASM PROGRESSION
4%
TACHYCARDIA
4%
RESPIRATORY TRACT INFECTION VIRAL
3%
FEBRILE NEUTROPENIA
2%
PNEUMONIA
1%
SEPSIS
1%
NEUTROPENIC INFECTION
1%
GASTRITIS
1%
SEIZURE
1%
ANAPHYLACTIC REACTION
1%
APPENDICITIS
1%
PULMONARY EMBOLISM
1%
CHOLELITHIASIS
1%
CELLULITIS
1%
DEVICE RELATED INFECTION
1%
ERYSIPELAS
1%
VASCULAR DEVICE INFECTION
1%
METASTASES TO MENINGES
100%
80%
60%
40%
20%
0%
Study treatment Arm
Veliparib Placebo With Carboplatin and Paclitaxel
Veliparib With Carboplatin and Paclitaxel

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (liposomal irinotecan, veliparib)Experimental Treatment5 Interventions
Patients receive liposomal irinotecan IV over 90 minutes on days 1 and 15 and veliparib PO BID on days 5-12 and 19-25 or 3-12 and 17-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Within 2-6 days prior to beginning liposomal irinotecan treatment, patients may optionally receive FMX IV and undergo MRI at baseline and 24 hours after FMX infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Veliparib
2012
Completed Phase 3
~4820
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Irinotecan Sucrosofate
2021
Completed Phase 2
~10
Ferumoxytol
2011
Completed Phase 4
~4380

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,105 Total Patients Enrolled
Susan BatesPrincipal InvestigatorMayo Clinic Cancer Center LAO
Susan E BatesPrincipal InvestigatorYale University Cancer Center LAO

Media Library

Liposomal Irinotecan (Topoisomerase I inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02631733 — Phase 1
Cancer Research Study Groups: Treatment (liposomal irinotecan, veliparib)
Cancer Clinical Trial 2023: Liposomal Irinotecan Highlights & Side Effects. Trial Name: NCT02631733 — Phase 1
Liposomal Irinotecan (Topoisomerase I inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02631733 — Phase 1

Frequently Asked Questions

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

What health consequences should be taken into account when using Veliparib?

"The safety of Veliparib has been tentatively rated as a 1 on our scale due to the limited evidence from Phase 1 trials indicating both efficacy and security."

Answered by AI

How many venues is this clinical experiment currently taking place in?

"At this time, 6 clinical trial locations in cities such as Cleveland and Rochester are running the medical experiment. It is advised that participants select a site close to their home to limit travelling demands."

Answered by AI

What is the purpose of this experiment?

"This 4-week clinical trial seeks to establish the maximum tolerated and recommended phase II dose of liposomal irinotecan in combination with veliparib. Secondary outcomes include an objective response rate, a clinical benefit rate (as evaluated according to RECIST v1.1), and progression free survival (defined as time from start of treatment until disease progression or death)."

Answered by AI

Has Veliparib been previously put to the test in any other scientific experiments?

"Presently, there are 294 Veliparib clinical trials in progress around the world - 59 of these studies have progressed to Phase 3. Though many of the examinations for this drug occur in Woolloongabba, Queensland, an impressive 11260 global sites are running investigations into its efficacy and safety."

Answered by AI

What is the current number of participants engaged in this trial?

"Unfortunately, this research trial is not currently enrolling participants. It was initially posted on July 15th 2016 and last modified November 8th 2022. Nonetheless, there are still 91 studies recruiting patients with malignant solid neoplasms in addition to 294 trials looking for Veliparib enrollees."

Answered by AI

Are there any remaining slots for volunteers in this research trial?

"According to clinicaltrials.gov, the posted trial is not presently accepting participants; it was first listed on July 15th 2016 and last updated in November 8th 2022. Despite this trial's current non-participatory status, there are a multitude of other studies currently seeking enrolment from volunteer patients."

Answered by AI

What therapeutic applications have been identified for Veliparib?

"Veliparib has been clinically tested to treat iron deficiency anemia, colon cancer, and ovarian carcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors
2017. "Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02631733.
~1 spots leftby Jul 2024
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