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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
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.
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGObjective 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.
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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.