Study of Pazopanib Combined With Palbociclib for Refractory Solid Tumors With Co-amplified in the 11q13(FGF3/4/19/CCND1)

NCT06895733 | Recruiting Phase 1

• 1 other identifier: MyCustom-Basket trials-PaPa
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy and safety of Pazopanib combined with Palbociclib in the third line and above treatment of refractory solid tumors co amplified in the 11q13 region (FGF3/4/19/CCND1).

Conditions

Solid Tumor, Adult; Next-generation Sequencing; Precision Medicine

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1) for cohort1 and cohort2.

  Through study completion, an expected average of 1 year.

• PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1)

  For cohort3,the time to progression-free survival during the substudy (PFS2) exceeds the documented time to disease progression-free survival during the last treatment prior to substudy entry (PFS1) by at least 35% (ie, PFS2/PFS1≥1.3) or, if PFS1 is not evaluable, time to progressive disease exceeds 6 months.

  Through study completion, an expected average of 1 year.

Secondary Outcomes (5)

• Progression Free Survival(PFS)

  From treatment administration up to a maximum duration of 18 months

• Overall Survival(OS)

  From treatment administration up to a maximum duration of 18 months

• Disease Control Rate (DCR)

  From treatment administration up to a maximum duration of 18 months

• Time to response (TTR)

  From treatment administration up to a maximum duration of 18 months.

• Percentage of Participants With Adverse Events (AEs)

  From treatment administration up to a maximum duration of 18 months.

Study Arms (3)

Uroepithelial carcinoma

EXPERIMENTAL

Uroepithelial carcinoma with co-amplification of 11q13 region(FGF3/4/19/CCND1) or FGFR1/FGFR2 amplification

Drug: Pazopanib Oral Tablet; Drug: Palbociclib

Head and neck squamous cell carcinoma

EXPERIMENTAL

Head and neck squamous cell carcinoma co-amplified in the 11q13 region(FGF3/4/19/CCND1)

Drug: Pazopanib Oral Tablet; Drug: Palbociclib

Other solid carcinoma

EXPERIMENTAL

Other solid carcinoma co-amplified in the 11q13 region(FGF3/4/19/CCND1)

Drug: Pazopanib Oral Tablet; Drug: Palbociclib

Interventions

Pazopanib Oral Tablet DRUG

Orally administered once daily (100mg)for 21 consecutive days, followed by a 7-day cessation of medication; Every 28 days is a treatment cycle.

Head and neck squamous cell carcinoma; Other solid carcinoma; Uroepithelial carcinoma

Palbociclib DRUG

Oral treatment once a day, with a cycle of 28 days. In the safety introduction section, the initial dose of pazopanib is 400mg, and in the dose escalation queue, the dose of pazopanib is 600mg.

Head and neck squamous cell carcinoma; Other solid carcinoma; Uroepithelial carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily join this study and sign an informed consent form;
• ≥ 18 years old;
• Patients with metastatic solid tumors diagnosed by histology or cytology; Queue 1:11q13 co amplified or FGFR1/FGFR2 amplified urothelial carcinoma Queue 2: Head and neck squamous cell carcinoma co amplified in 11q13 region Queue 3:11q13 co amplified other solid tumors
• Disease progression or intolerable toxicity confirmed by imaging during or after treatment with at least two standard treatment regimens in the past;
• According to RECIST 1.1, there must be at least one measurable lesion;
• Can swallow pills normally;
• ECOG score: 0-2;
• Expected survival period ≥ 12 weeks;
• The function of important organs meets the following requirements (no blood components or cell growth factor drugs are allowed to be used within 14 days before the first medication):
• Absolute neutrophil count ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Serum total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN, and if there is liver metastasis, ALT and AST ≤ 5ULN; AKP≤ 2.5×ULN；Serum creatinine ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 (not receiving anticoagulant therapy);
• Non surgical sterilization or female patients of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum or urine HCG test within 7 days prior to their first medication; And it must be during non lactation period; For male patients whose partners are women of childbearing age, effective contraception methods should be used during the trial period and within 3 months after the last administration of the trial drug.

You may not qualify if:

• Known history or evidence of interstitial lung disease or active non infectious pneumonia;
• Known to have central nervous system metastases;
• Within the past 5 years or simultaneously with other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
• Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); Allow the above parameters to be achieved through the use of antihypertensive therapy; Previously experienced hypertensive crisis or hypertensive encephalopathy;
• There are uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, (5) QTc\>450ms (male); QTc\>470ms (female);
• For those undergoing thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin and low molecular weight heparin is allowed;
• Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies; If fecal occult blood is positive during the baseline period, a follow-up examination can be conducted. If the result is still positive after the follow-up examination, gastroscopy examination is required;
• Tumor invasion of important blood vessels, or the possibility of tumor invasion of important blood vessels in the future research period determined by imaging, may lead to fatal bleeding;
• If the patient has pleural effusion, ascites, or pericardial effusion that requires drainage, and the researcher evaluates the symptoms to be stable after drainage, they can be enrolled;
• Occurrence of arterial/venous thrombosis events within the first 6 months of enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
• Known genetic or acquired bleeding and thrombophilia tendencies (such as in hemophilia patients, coagulation dysfunction, etc.);
• Within 6 months prior to the start of treatment, there has been an abdominal fistula, gastrointestinal perforation, or abdominal abscess;
• Significant vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occurred within 6 months prior to the start of the study treatment;
• Severe, unhealed, or cracked wounds, as well as active ulcers or untreated fractures;
• Received major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study treatment or expected to undergo major surgical treatment during the study period;

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Interventions

pazopanib; palbociclib

Central Study Contacts

Haitao Wang, Ph.D

CONTACT

+86-022-88326385; peterrock2000@126.com

Jinhuan Wang, Ph.D

CONTACT

+86-022-88326610; wjhhappy2008@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 26, 2025
• Study Start: November 27, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)