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RecruitingNCT06895733Updated Mar 26, 2025

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

A Phase 1/2 interventional study of Pazopanib Oral Tablet and Palbociclib in Solid Tumor, Adult, Next-generation Sequencing and Precision Medicine, sponsored by Tianjin Medical University Second Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Tianjin Medical University Second Hospital · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Nov 2024, registered Mar 2025).
  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
65
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

Based on literature review, this study first conducted a phase Ib study to observe the dose limiting toxicity (DLTs) of the combination therapy of pazopanib and palbociclib and to determine the recommended dose for phase II study (RP2D); Further phase II studies will be conducted to evaluate the efficacy of pazopanib combined with palbociclib in the third line and above treatment of refractory solid tumors co amplified in the 11q13 region using objective response rate (ORR) or progression free survival 2/progression free survival 1 (PFS2/PFS1). And observe and evaluate the progression free survival (PFS), time to remission (TTR), disease control rate (DCR), and overall survival (OS) of pazopanib combined with palbociclib for third line and above treatment of refractory solid tumors co amplified in the 11q13 region. Evaluate the safety of Pazopanib combined with palbociclib for the third line and above treatment of refractory solid tumors co amplified in the 11q13 region.

02

Conditions studied

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

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 65 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Tianjin Medical University Second Hospital is the lead sponsor of 57 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily join this study and sign an informed consent form;
  2. ≥ 18 years old;
  3. 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
  4. Disease progression or intolerable toxicity confirmed by imaging during or after treatment with at least two standard treatment regimens in the past;
  5. According to RECIST 1.1, there must be at least one measurable lesion;
  6. Can swallow pills normally;
  7. ECOG score: 0-2;
  8. Expected survival period ≥ 12 weeks;
  9. 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);

  10. 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.

Exclusion criteria

Exclusion Criteria:

  1. Known history or evidence of interstitial lung disease or active non infectious pneumonia;
  2. Known to have central nervous system metastases;
  3. Within the past 5 years or simultaneously with other malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);
  4. 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;
  5. 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);
  6. For those undergoing thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin and low molecular weight heparin is allowed;
  7. 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;
  8. 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;
  9. 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;
  10. 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;
  11. Known genetic or acquired bleeding and thrombophilia tendencies (such as in hemophilia patients, coagulation dysfunction, etc.);
  12. Within 6 months prior to the start of treatment, there has been an abdominal fistula, gastrointestinal perforation, or abdominal abscess;
  13. 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;
  14. Severe, unhealed, or cracked wounds, as well as active ulcers or untreated fractures;
  15. 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;
  16. Urine routine shows that urine protein is ≥++and has been confirmed to have a 24-hour urine protein level>1.0 g;
  17. Previously received radiotherapy (excluding palliative radiotherapy for bone lesions), chemotherapy, surgery (excluding biopsy), and less than 4 weeks before the first study medication after completion of treatment (last medication); The last dose of antibody administration is less than 4 weeks after the first study medication; Molecular targeted therapy (including other oral targeted drugs used in clinical trials) for patients with less than 5 drug half lives from the first study drug, or adverse reactions caused by previous treatment (excluding hair loss) that have not recovered to ≤ CTCAE grade 1;
  18. Suffering from active infection, having unexplained fever ≥ 38.5 ℃ within 7 days before medication, or baseline white blood cell count>15 × 109/L;
  19. Suffering from congenital or acquired immune dysfunction (such as HIV infected individuals); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU/ml, or hepatitis C virus antibody positive;
  20. Previously received anti angiogenic therapy;
  21. According to the researchers' judgment, the patient may have other factors that may affect the research results or cause the study to be terminated midway, such as alcohol abuse, drug abuse, other serious illnesses (including mental illnesses) that require concomitant treatment, serious laboratory test abnormalities, and family or social factors that may affect the patient's safety.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    Uroepithelial carcinoma

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

    Drug: Pazopanib Oral Tablet · Drug: Palbociclib

  • Experimental
    Head and neck squamous cell carcinoma

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

    Drug: Pazopanib Oral Tablet · Drug: Palbociclib

  • Experimental
    Other solid carcinoma

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

    Drug: Pazopanib Oral Tablet · Drug: Palbociclib

Interventions

  • DrugPazopanib Oral Tablet

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

  • DrugPalbociclib

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an expected average of 1 year.

  2. 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.

    Time frame: Through study completion, an expected average of 1 year.

Secondary outcomes

  1. Progression Free Survival(PFS)

    The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1

    Time frame: From treatment administration up to a maximum duration of 18 months

  2. Overall Survival(OS)

    Time from start of treatment to death due to any cause.

    Time frame: From treatment administration up to a maximum duration of 18 months

  3. Disease Control Rate (DCR)

    The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects 12 months after the last subject participating in.

    Time frame: From treatment administration up to a maximum duration of 18 months

  4. Time to response (TTR)

    TTR (per RECIST 1.1) is defined as the time from the starting date of study drug to the first time complete response (CR) or partial response (PR) 12 months after the last subject participating in.

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

  5. Percentage of Participants With Adverse Events (AEs)

    Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0.

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

07

Study locations

1 of 1 sites recruiting
  • Tianjin Medical Unversity Second Hospital
    Tianjin, Tianjin 300211, China
    • Haitao Wang · Contact · peterrock2000@126.com · +86-02288326610
    • Lili Wang · Contact · wangliliaigang@163.com · +86-13516108466
    • Haitao Wang · Principal investigator
    • Lili Wang · Sub investigator
    • Dingkun Hou · Sub investigator
    • Jinhuan Wang · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06895733
Lead sponsor
Tianjin Medical University Second Hospital
Responsible party
Sponsor
First posted
Mar 26, 2025
Start date
Nov 27, 2024
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Mar 26, 2025

Study contacts

Haitao Wang, Ph.D
Contact
peterrock2000@126.com
+86-022-88326385
Jinhuan Wang, Ph.D
Contact
wjhhappy2008@163.com
+86-022-88326610

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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