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Tyrosine Kinase Inhibitor

Pazopanib + PCI-24781 for Metastatic Cancer

Phase 1
Waitlist Available
Led By Pamela Munster, MD
Research Sponsored by Pamela Munster
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically or cytologically confirmed locally advanced, solid tumor malignancies of specific tumor types for Phase Ib
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well against solid tumors.

Who is the study for?
Adults with advanced solid tumors who have adequate organ function and no recent transfusions. Women must be non-pregnant, not nursing, and using contraception if of childbearing potential. Excludes those with certain heart conditions, uncontrolled infections, or brain metastases.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs, Pazopanib and PCI-24781, to find the safest dose for treating advanced solid tumors. It's an early-phase study where everyone gets the treatment without being compared to a control group.See study design
What are the potential side effects?
Possible side effects include increased risk of bleeding, gastrointestinal issues that could lead to bleeding or affect drug absorption, liver problems indicated by bilirubin levels, high blood pressure, and potential QT interval prolongation affecting heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, confirmed by lab tests, and matches the specific types needed for Phase Ib.
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I am 18 years old or older.
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My cancer has spread and this was confirmed by lab tests.
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I am fully active or can carry out light work.
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All my side effects from cancer treatment are mild, except for hair loss.
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It's been over 4 weeks or five half-lives since my last cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity (DLT)
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Duration of Response (DoR)
Establish the area under the curve (AUC) of PCI-24781, pazopanib and the combination of the two drugs.
+7 more

Side effects data

From undefined Phase 1 & 2 trial • 55 Patients • NCT00724984
57%
FATIGUE
50%
NAUSEA
50%
DIARRHOEA
50%
COUGH
36%
OEDEMA PERIPHERAL
36%
CHILLS
29%
THROMBOCYTOPENIA
29%
ANAEMIA
29%
SINUSITIS
29%
DYSPNOEA
21%
RASH
21%
CONSTIPATION
21%
VOMITING
21%
DECREASED APPETITE
21%
HEADACHE
21%
NEUTROPENIA
21%
DYSGEUSIA
14%
MUSCLE SPASMS
14%
ABDOMINAL PAIN
14%
FLATULENCE
14%
UPPER RESPIRATORY TRACT INFECTION
14%
BACK PAIN
14%
ARTHRALGIA
14%
DEHYDRATION
14%
HYPERGLYCAEMIA
14%
MUSCULAR WEAKNESS
14%
RHINORRHOEA
7%
PETECHIAE
7%
PERIPHERAL SENSORY NEUROPATHY
7%
LEUKOPENIA
7%
CELLULITIS
7%
FREQUENT BOWEL MOVEMENTS
7%
HYPOMAGNESAEMIA
7%
PRURITUS
7%
GROIN PAIN
7%
EPISTAXIS
7%
HYPOTENSION
7%
HYPOGLYCAEMIA
7%
LYMPH NODE PAIN
7%
VISUAL ACUITY REDUCED
7%
ABDOMINAL DISTENSION
7%
ARTHROPATHY
7%
DYSPEPSIA
7%
ERUCTATION
7%
GASTROOESOPHAGEAL REFLUX DISEASE
7%
RECTAL HAEMORRHAGE
7%
STOMATITIS
7%
CHEST DISCOMFORT
7%
CHEST PAIN
7%
EARLY SATIETY
7%
INFLUENZA LIKE ILLNESS
7%
LOCALISED OEDEMA
7%
PERFORMANCE STATUS DECREASED
7%
PYREXIA
7%
CANDIDIASIS
7%
INFECTED BITES
7%
NASOPHARYNGITIS
7%
OTITIS MEDIA
7%
PNEUMONIA
7%
TOOTH INFECTION
7%
URINARY TRACT INFECTION
7%
ARTHROPOD BITE
7%
ASPARTATE AMINOTRANSFERASE INCREASED
7%
BLOOD LACTATE DEHYDROGENASE INCREASED
7%
HAEMOGLOBIN
7%
WEIGHT DECREASED
7%
WEIGHT INCREASED
7%
HYPERKALAEMIA
7%
HYPERNATRAEMIA
7%
HYPOPHOSPHATAEMIA
7%
INCREASED APPETITE
7%
MUSCULOSKELETAL PAIN
7%
MYALGIA
7%
PAIN IN EXTREMITY
7%
AREFLEXIA
7%
ATAXIA
7%
INTENTION TREMOR
7%
LOSS OF CONSCIOUSNESS
7%
MEMORY IMPAIRMENT
7%
MOTOR DYSFUNCTION
7%
NEUROPATHY PERIPHERAL
7%
ANXIETY
7%
INSOMNIA
7%
MICTURITION URGENCY
7%
NOCTURIA
7%
URINARY INCONTINENCE
7%
DYSPNOEA EXERTIONAL
7%
HICCUPS
7%
NASAL CONGESTION
7%
OROPHARYNGEAL PAIN
7%
PULMONARY CONGESTION
7%
RALES
7%
ALOPECIA
7%
DRY SKIN
7%
HYPERHIDROSIS
7%
TROPONIN INCREASED
7%
BLOOD CREATININE INCREASED
7%
SPINAL COLUMN STENOSIS
7%
JUGULAR VEIN THROMBOSIS
7%
HAEMORRHOIDAL HAEMORRHAGE
7%
ATRIAL FIBRILLATION
7%
MELAENA
7%
LYMPHOPENIA
7%
SINUS TACHYCARDIA
7%
ABDOMINAL PAIN UPPER
7%
APHTHOUS STOMATITIS
7%
HYPERBILIRUBINAEMIA
7%
HYPERURICAEMIA
7%
ALLERGY TO ARTHROPOD BITE
7%
HYPOALBUMINAEMIA
7%
HYPOCALCAEMIA
7%
HYPOKALAEMIA
7%
FLUSHING
7%
CLUBBING
7%
NECK PAIN
7%
DIZZINESS
7%
TENSION HEADACHE
7%
PLATELET COUNT DECREASED
7%
DRY EYE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mantle Cell Lymphoma/Phase II
Cohort 1(30 mg/m2, 5days/wk)/Phase I
Cohort 2(45 mg/m2, 5days/wk)/Phase I
Cohort 3(45 mg/m2, 7days/wk)/Phase I
Cohort 4(60 mg/m2,7days/wk)/Phase I
Follicular/Phase II

Trial Design

1Treatment groups
Experimental Treatment
Group I: Panobinostat with PC124871Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Pamela MunsterLead Sponsor
7 Previous Clinical Trials
91 Total Patients Enrolled
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,730 Total Patients Enrolled
NovartisIndustry Sponsor
1,607 Previous Clinical Trials
2,709,701 Total Patients Enrolled

Media Library

Pazopanib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01543763 — Phase 1
Metastatic Tumor Research Study Groups: Panobinostat with PC124871
Metastatic Tumor Clinical Trial 2023: Pazopanib Highlights & Side Effects. Trial Name: NCT01543763 — Phase 1
Pazopanib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01543763 — Phase 1

Frequently Asked Questions

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

Are there any existing opportunities for participants to join the research?

"Per the details available on clinicaltrials.gov, this research is actively attempting to find patients. The study was posted on June 25th 2012 and last edited August 24th 2022."

Answered by AI

Is this research a pioneering endeavor into uncharted medical territory?

"Investigated since 2010, PZP115891 and PCI-24781 was initially sponsored by Secura Bio, Inc. for a Phase 1 clinical trial that included 18 patients in the same year. Subsequently approved as a drug, it is now being studied across 38 countries and 676 cities with 43 ongoing trials."

Answered by AI

What are the primary ailments that PZP115891 and PCI-24781 have been found to ameliorate?

"According to research, PZP115891 and PCI-24781 have been demonstrated as efficacious treatments for advanced thyroid cancer, refractory multiple myeloma, and soft tissue sarcoma (STS)."

Answered by AI

What primary goals are investigators looking to accomplish with this experiment?

"The primary end-point of this study, which will be observed over a four week period, is dose limiting toxicity (DLT). Additionally, secondary objectives include establishing the area under concentration curve (AUC), determining bioavailability and calculating volume of distribution in regards to PCI-24781, pazopanib and their combination."

Answered by AI

How many participants are actively engaged in this experiment?

"Affirmative. Clinicaltrials.gov data reveals that this clinical experiment, whose inception was June 25th 2012, is actively seeking participants. Approximately 120 patients need to be enrolled from a single medical centre."

Answered by AI

What potential risks does exposure to PZP115891, PCI-24781 pose for those participating in the trial?

"As this is a Phase 1 trial and thus has only minimal evidence supporting its safety and efficacy, PZP115891/PCI-24781 was awarded a score of one."

Answered by AI
~7 spots leftby Mar 2025