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
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).
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.
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 →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.
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);
Exclusion Criteria:
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 co-amplified in the 11q13 region(FGF3/4/19/CCND1)
Drug: Pazopanib Oral Tablet · Drug: Palbociclib
Other solid carcinoma co-amplified in the 11q13 region(FGF3/4/19/CCND1)
Drug: Pazopanib Oral Tablet · Drug: Palbociclib
Orally administered once daily (100mg)for 21 consecutive days, followed by a 7-day cessation of medication; Every 28 days is a treatment cycle.
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.
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.
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.
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
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
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
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tianjin Medical University Second Hospital