Phase I Clinical and Pharmacokinetic Study of Pazopanib in a Population of Frail Elderly Patients… (NCT01642017) | Clinical Trial Compass
TerminatedPhase 1
Phase I Clinical and Pharmacokinetic Study of Pazopanib in a Population of Frail Elderly Patients According SIOG Criteria
Stopped: Slow recruitment rate
France18 participantsStarted 2012-11-22
Plain-language summary
This is an open-label, multicenter, non-randomized, phase 1 dose escalation clinical trial to determine the MTD (Maximal Tolerated Dose) of Pazopanib in a population of frail elderly patients, selected according to the International Society of Geriatric Oncology (SIOG)classification (Group 2).
It is expected that a total number of 30 patients maximum will be enrolled in the study on 30 months : 18 months accrual - 12 months follow up.
Eligible patients will be enrolled into a standard 3+3 design with a starting dose of Pazopanib administered orally at 400 mg per day, in 28-day cycles. Then, further dose levels will be explored.
Toxicity of the schedule will be assessed during the first cycle. Patients will receive study medication until disease progression. After treatment discontinuation, patients will be followed during one year.
Who can participate
Age range75 Years
SexALL
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Inclusion criteria
✓. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.
✓. Age ≥ to 75 years old
✓. Patient with metastatic cancer among renal cell carcinoma, non small cell lung cancer, pancreatic neuroendocrine cancer, sarcoma , ovarian cancer , thyroid cancer, bladder cancer or breast cancers, who cannot receive any treatment with curative intent.
✓. WHO PS ≤ 2,
✓. Life expectancy ≥ 3 months,
✓. Group 2 (vulnerable) according to SIOG classification,
✓. Adequate organ system function as defined in provided Table
Exclusion criteria
✕. Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA \<1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, and who is deemed at low risk for recurrence by his/her treating physician,
What they're measuring
1
Dose limiting toxicity (DLT) incidence (according DLT definition) during the first treatment cycle with pazopanib (28 days)
✕. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.
✕. Criteria of group 3 according to SIOG classification,
✕. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
✕. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
✕. Presence of uncontrolled infection.
✕. Corrected QT interval (QTc) \> 480 msecs using Bazett's formula
✕. Anti-coagulants treatment (preventive or curative)