Pazopanib + PCI-24781 for Metastatic Cancer

Overseen By Early Phase Cancer Clinical Trials Recruitment

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pamela Munster

Must not be taking: QT prolonging drugs

Disqualifiers: Active infections, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a open-label non-randomized, dose escalation and expansion Phase Ia/Ib study to determine the safety, tolerability and maximum tolerated dose (MTD) of pazopanib in combination with PCI-24781 in patients with advanced solid tumors.

Research Team

Pamela Munster, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

My cancer is advanced, confirmed by lab tests, and matches the specific types needed for Phase Ib.

Measurable disease by RECIST 1.1

It's been over 4 weeks or five half-lives since my last cancer treatment.

Exclusion Criteria

I haven't had any cancer except for skin cancer in the last 5 years.

I have serious stomach or intestine problems that could cause bleeding.

I do not have active hepatitis C or B, HIV, or any uncontrolled infection.

Treatment Details

Interventions

• Pazopanib
• PCI-24781

Trial Overview 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.

Participant Groups

Group I: Panobinostat with PC124871 Experimental Treatment 1 Intervention

Pazopanib is already approved in United States, European Union, China for the following indications:

Approved in United States as Votrient for:

• Advanced renal cell carcinoma (kidney cancer)
• Soft tissue sarcoma

Approved in European Union as Votrient for:

• Advanced renal cell carcinoma (kidney cancer)
• Soft tissue sarcoma

Approved in China as pazopanib for:

• Metastatic renal cell carcinoma (mRCC)

Who Is Running the Clinical Trial?

Pamela Munster

Lead Sponsor

Trials

8

Recruited

180+

Pharmacyclics LLC.

Industry Sponsor

Trials

114

Recruited

13,800+

Dr. Maky Zanganeh

Pharmacyclics LLC.

Chief Executive Officer

Degree from Louis Pasteur University in Strasbourg, France; MBA from Schiller International University in France

Dr. Ellie Im

Pharmacyclics LLC.

Chief Medical Officer

MD from an unspecified institution

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

GlaxoSmithKline Research and Education Foundation for Cardiovascular Disease

Collaborator

Trials

1

Recruited

90+

Xynomic Pharmaceuticals, Inc.

Industry Sponsor

Trials

11

Recruited

1,200+