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Tyrosine Kinase Inhibitor

Cabozantinib + Pamiparib for Advanced Cancer

Phase 1
Waitlist Available
Led By Siqing Fu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have one of the specified genetic and pathologic features as defined in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory
Patients must be able to take oral medications without medical history of malabsorption or other chronic gastrointestinal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial finds the best dose and side effects of cabozantinib and pamiparib in treating patients with advanced or refractory solid tumors.

Who is the study for?
Adults with advanced solid tumors that are resistant to standard treatments or have no standard treatment options available. Participants must have specific genetic markers related to tumor growth, be able to take oral medication, and not have had certain recent treatments. They should also meet various health criteria like adequate blood cell counts and organ function, agree to use effective contraception, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs, Cabozantinib and Pamiparib, for their effectiveness in stopping tumor growth by inhibiting enzymes needed for cell proliferation. It aims to determine the optimal dosages and document any side effects when used together on patients with refractory advanced solid tumors.See study design
What are the potential side effects?
Potential side effects may include but are not limited to fatigue, digestive issues such as nausea or diarrhea, changes in blood pressure or heart rhythm disturbances (QTc prolongation), liver enzyme alterations indicating potential liver damage, possible bleeding complications if taking anticoagulants concurrently, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition has a specific genetic feature confirmed by a certified lab.
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I can take pills and do not have chronic stomach or absorption problems.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am willing to provide tissue samples for the study.
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I have not been treated with drugs that target PARP and VEGF at the same time.
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My cancer can be measured or seen on scans.
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I am 18 years old or older.
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I haven't had radiation aimed at relieving symptoms on my only cancer spots during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months 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 toxicities
Incidence of adverse events
Recommended phase 2 dosage

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PAIN IN EXTREMITY
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
DIZZINESS
14%
BILIRUBIN INCREASED
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
ALKALINE PHOSPHATASE INCREASED
9%
ORAL PAIN
9%
TUMOR PAIN
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
INSOMNIA
5%
RASH
5%
Peripheral Sensory Neuropathy
5%
SINUS BRADYCARDIA
5%
HEMATURIA
5%
HYPERTHYROIDISM
5%
Sore Throat
5%
Hypertension
5%
ANXIETY
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Hoarseness
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Stomach Pain
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
TENDONITIS
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib, pamiparib)Experimental Treatment2 Interventions
Patients receive cabozantinib PO QD and pamiparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Pamiparib
2017
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,405 Total Patients Enrolled
Siqing FuPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
498 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05038839 — Phase 1
Cancer Research Study Groups: Treatment (cabozantinib, pamiparib)
Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT05038839 — Phase 1
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038839 — Phase 1

Frequently Asked Questions

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

Have any other research projects explored the effects of Cabozantinib?

"Currently, there are 118 active studies on Cabozantinib with 12 at Phase 3. While concentrated in Cordoba and Calabria, over 7000 different clinical sites around the world are conducting trials revolving around this drug."

Answered by AI

Are there any slots remaining for participation in this trial?

"As confirmed on the clinicaltrials.gov website, this medical trial is in progress. It was initially advertised to the public on February 9th 2022 and has been edited as recently as July 31st of that same year."

Answered by AI

For what medical conditions is Cabozantinib commonly prescribed?

"Cabozantinib is usually prescribed as a follow up to anti-VEGF therapy. It also has been found useful in treating advanced renal cell carcinoma (ARCC) and adrenal medulla for high risk patients."

Answered by AI

Could you elucidate on the safety profile of Cabozantinib?

"Due to the preliminary nature of this clinical trial, cabozantinib's safety rating is a 1 on our scale. This score reflects the fact that we have limited data regarding its efficacy and security."

Answered by AI

Is this an unprecedented examination?

"Since its first research trial in 2012, sponsored by Exelixis and involving 86 participants, Cabozantinib has been thoroughly studied. It was subsequently approved for Phase 2 drug trials and is presently the subject of 118 studies spanning 1370 cities and 45 countries worldwide."

Answered by AI

What is the size of the cohort involved in this trial?

"Affirmative. Clinicaltrials.gov reveals that this experiment, which was initially advertised on February 9th 2022, is currently searching for volunteers. 44 participants are necessary from 1 medical facility."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~3 spots leftby Jun 2024