A Phase I, Exploratory, Intra-patient Dose Escalation Study to Investigate the Preliminary Safety… (NCT01652547) | Clinical Trial Compass
CompletedPhase 1
A Phase I, Exploratory, Intra-patient Dose Escalation Study to Investigate the Preliminary Safety, Pharmacokinetics, and Anti-tumor Activity of Pasireotide (SOM230) s.c.Followed by Pasireotide LAR in Patients With Metastaticmelanoma or Metastatic Merkel Cell Carcinoma
This study will evaluate the preliminary safety, pharmacokinetics, and anti-tumor activity of pasireotide s.c. in patients with metastatic melanoma or metastatic Merkel cell carcinoma. The study consists of three phases: screening, intra-patient dose-escalation, and follow-up phases.
In the screening phase patient will be informed of all aspects of the study and sign informed consent forms and then be screened for study eligibility.
During the intra-patient dose escalation phase, 18 patients will be treated with pasireotide s.c. 300 μg t.i.d. for 2 weeks. If there are no unacceptable AEs, defined as drug-related clinically meaningful, uncontrolled grade 3 or any grade 4 toxicities, patients will be dose escalated to 600 μg t.i.d. for 2 more weeks, then 900 μg t.i.d. for 2 weeks and then 1200 μg for 2 weeks provided that there are no unacceptable AEs. Each patient will be in the dose escalation phase for a maximum of 8 weeks.
At end of the intra-patient dose escalation phase, patients will be allowed to switch to 80 mg pasireotide LAR i.m. q 28 d (or a lower dose in case of toxicity) for an additional 6 months or until disease progression, or unacceptable AEs, or patient withdraws consent. In addition, all patients will keep their pasireotide s.c. t.i.d. treatment (same dose as that at the end of the 8-week dose escalation phase) during the first 2 weeks of the LAR follow-up phase, except on the day receiving the first LAR dose because of an anticipated initial burst of drug release.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have histologically or cytologically confirmed unresectable (stage III) and/or metastatic (stage IV) melanoma or unresectable and/or metastatic Merkel cell carcinoma.
✓. Melanoma patients should have no mutation in BRAF and NRAS genes
✓. Patients should have lesions that can be biopsied, in addition measurable and non-measurable metastatic lesions and at 1 lesion suitable for 18FDG-PET scan or CT/MRI.
✓. ECOG Performance Status of 0 or 1
✓. Presence of measurable or non-measurable disease according to RECIST 1.0
✓. Adequate organ function: adequate bone marrow function (WBC ≥ 2.5 x 109/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 9 g/dL); serum creatinine ≤ 1.5 mg/dL or estimated glomerular filtration rate (eGFR) \> 40 ml/min/m2; serum lipase ≤ 1.5 ULN
Exclusion criteria
✕. Patient with primary uveal melanoma
✕. Patients with symptomatic CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
What they're measuring
1
Number of patients with AEs, SAEs
Timeframe: Week 8
2
Number of patients with laboratory abnormalities and changes in laboratory values
Timeframe: Week 8
3
Number of patients with electrocardiographic abnormalities and changes in electrocardiograms readings
Timeframe: Week 8
4
Number of patients with vital sign abnormalities and changes in vital signs
✕. Patient who have been previously treated with somatostatin analogue or radiolabeled somatostatin analogs or patients with a known hypersensitivity to somatostatin analogs or any component of the pasireotide s.c. and i.m. formulations or their excipients
✕. Patients for whom standard treatment is available and indicated due to rapidly progressive or aggressive disease
✕. Patients who received more than 3 prior lines of systemic therapy for the treatment of the disease.
✕. Patients receiving any anti-neoplastic therapy within the 4 weeks prior to baseline
✕. Patients receiving an investigational drug within 1 month prior to baseline
✕. Patients who have undergone major surgery/surgical therapy for any cause within 1 month prior to baseline. Patients must have recovered from the treatment and have a stable clinical condition before entering this study