Metastatic Melanoma and Merkel Cell CarcinomaPhase 1NCT01652547
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
A Phase 1 study testing Pasireotide sub-cutaneous formulation and Pasireotide lon acting release formulation in people with Metastatic Melanoma and Merkel Cell Carcinoma, run by Novartis Pharmaceuticals at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma and Merkel Cell Carcinoma
- What is being tested?
- Pasireotide sub-cutaneous formulation and Pasireotide lon acting release formulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2012to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
Show all 36Show fewer
- 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
- Patients who have received prior radiation therapy ≤ 4 weeks, or limited field radiation ≤ 2 weeks, prior to baseline or the side effects of such therapy have not resolved to ≤ grade 1.
- Patients unwilling to perform repeated biopsies
- Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be included)
- Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits)
- Patients on continuous anticoagulation therapy. Patients who were on anticoagulant therapy must complete a washout period of at least 10 days prior to baseline and have confirmed normal coagulation parameters before study inclusion
- Patients who are not biochemically euthyroid
- Patients with known history of hypothyroidism are eligible if they are on adequate and stable replacement thyroid hormone therapy for at least 3 months prior to baseline
- Patients with QT-related exclusion criteria
- Baseline QTcF >450 ms
- History of syncope or family history of idiopathic sudden death
- Known history of prolong QT syndrome
- Sustained or clinically significant cardiac arrhythmias
- Patients with risk factors for torsades de pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, clinically relevant cardiac failure (NYHA class III or IV), clinically significant/symptomatic bradycardia or high-grade AV block
- Concomitant medications known to prolong the QT interval
- Known concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes mellitus or Parkinson's disease), HIV, liver cirrhosis, uncontrolled hypothyroidism or cardiac failure
- Patients with unstable angina, sustained ventricular tachycardia, ventricular fibrillation, high grade (NOT advanced!) heart block or history of acute myocardial infarction less than one year prior to baseline
- Patients with any of the following severe and/or uncontrolled medical conditions:
- Uncontrolled diabetes as defined by HbA1c > 8% despite adequate therapy
- Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive HIV test result (ELISA and Western blot)
- Liver disease or history of liver disease such as cirrhosis, decompensated liver disease, or chronic active hepatitis B and C or chronic persistent hepatitis
- Life-threatening autoimmune and ischemic disorders
- Patients who have a history of another primary malignancy, with the exception of locally excised non-melanoma skin cancer and carcinoma in situ of uterine cervix. Patients who had no evidence of disease from another primary cancer for 3 or more years are allowed to participate in the study
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Patients with baseline ALT or AST > 3 x ULN or baseline total bilirubin > 1.5x ULN
- Patients with presence of Hepatitis B surface antigen (HbsAg) or presence of Hepatitis C antibody test (anti-HCV)
- History of, or current alcohol misuse/abuse within the past 12 months prior to visit 1 (baseline)
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Zurich, 8091
About this study
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.
Read more
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.
- Being tested
- Pasireotide sub-cutaneous formulation, Pasireotide lon acting release formulation
- Keywords
- Melanoma, Merkel cell carcinoma, Metastatic skin cancer
- Medical subject headings
- Melanoma, Carcinoma, Merkel Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide sub-cutaneous formulationDrug
Pasireotide, will be administered to all patients by s.c. injection, beginning with a dose of 300 μg administered three times daily (t.i.d.) for 2 weeks. If no pasireotide-related clinically meaningful/uncontrolled grade 3 or grade 4 adverse events occur the dose will be administered to all patients at an increased dose of 600 μg t.i.d. for 2 weeks, followed by 2 weeks of 900 μg t.i.d. and followed by 2 weeks of 1200 μg t.i.d. After the 8 weeks period, patients will be kept on treatment drug (highest dose without clinically meaningful/uncontrolled AEs) , switched to the corresponding pasireotide LAR dose and followed up for an extra 6 months.
Pasireotide lon acting release formulationDrug
At the start of the follow-up phase patients will be switched to pasireotide LAR administered intramuscularly every 28 days by using the following conversion algorithm so that the steady state PK exposure (Cmax and Ctrough) of pasireotide will be maintained: 300 μg s.c. t.i.d. fi 20mg LAR i.m. q 28 days 600 μg s.c. t.i.d. fi 40 mg LAR i.m. q 28 days 900 μg s.c. t.i.d. fi 60 mg LAR i.m. q 28 days 1200 μg s.c. t.id. fi 80 mg LAR i.m. q 28 days In addition, all patients will keep the treatment with pasireotide s.c. during the first 2 weeks of the LAR phase. The use of s.c. dosing during the initial 2 week period following the first LAR dose provides an appropriate level of medication during the LAR nadir.
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide sub-cutaneous formulation | Experimental | Pasireotide, will be administered to all patients by s.c. injection, beginning with a dose of 300 μg administered three times daily (t.i.d.) for 2 weeks. If no pasireotide-related clinically meaningful/uncontrolled grade 3 or grade 4 adverse events occur the dose will be administered to all patients at an increased dose of 600 μg t.i.d. for 2 weeks, followed by 2 weeks of 900 μg t.i.d. and followed by 2 weeks of 1200 μg t.i.d. After the 8 weeks period, patients will be kept on treatment drug (highest dose without clinically meaningful/uncontrolled AEs), switched to the corresponding pasireotide LAR dose and followed up for an extra 6 months. Receives: Drug: Pasireotide sub-cutaneous formulation |
| Pasireotide long acting release | Experimental | At the start of the follow-up phase patients will be switched to pasireotide LAR administered intramuscularly every 28 days by using the following conversion algorithm so that the steady state PK exposure (Cmax and Ctrough) of pasireotide will be maintained: 300 μg s.c. t.i.d. fi 20mg LAR i.m. q 28 days 600 μg s.c. t.i.d. fi 40 mg LAR i.m. q 28 days 900 μg s.c. t.i.d. fi 60 mg LAR i.m. q 28 days 1200 μg s.c. t.id. fi 80 mg LAR i.m. q 28 days In addition, all patients will keep the treatment with pasireotide s.c. during the first 2 weeks of the LAR phase. The use of s.c. dosing during the initial 2 week period following the first LAR dose provides an appropriate level of medication during the LAR nadir. Receives: Drug: Pasireotide lon acting release formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with AEs, SAEs
Number of patients with AEs (overall and by severity) SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Week 8
Number of patients with laboratory abnormalities and changes in laboratory values
Number of patients with laboratory abnormalities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Week 8
Number of patients with electrocardiographic abnormalities and changes in electrocardiograms readings
Number of patients with ECG according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Week 8
Number of patients with vital sign abnormalities and changes in vital signs
Number of patients with vital sign abnormalities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: Week 8
Secondary outcomes (9)
Changes in laboratory values, electrocardiograms readings, and vital signs values at study completion
Measured: Baseline, Day 253
Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as measured by disease control rate ((DCR), (Complete Response (CR), Partial Response (PR), Stable Disease (SD))
Tumor response as measured by DCR defined as the proportion of patients with best overall response of complete response (CR), partial response (PR) or stable response (SR) according to the RECIST Version 1.0 Criteria.
Measured: Baseline, Day 57, Day 113, Day 169, Day 225
PK parameters for each cycle on Day 1 (Cmax,d1 Tmax,d1, AUC0-2hr,d1), and on day 8 at steady state (Cmin,d8, Cmaxd8, Tmax,d8, Cavg,d8, AUC0-2hr,d8, ARd8)
Pasireotide plasma concentrations will be summarized by dose and time and PK profile of pasireotide concentration over time will be generated by dose.
Measured: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 85, 113, 141, 169, 197 and 225
Changes from baseline on melanoma response biomarkers (MIA, S100B) overtime and its correlation with each dose
Melanoma response biomarkers (MIA, S100B) will be evaluated in pre- and post-treatment samples on all patients to assess the biochemical response to pasireotide as change from baseline at Day 8, 15, 22, 29, 36, 43, 50, 57, 113, 169 and 225.
Measured: Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 113, 169 and 225
Changes from baseline and/or actual levels of potential response and/or secretion biomarkers over time, in repeated tumor and/or blood samples
PD and cellular effect makers in tumor Protein expression levels for different PD markers such as p4EBP-1, pS6, pAKT, pERK and for different cellular effect markers of proliferation and apoptosis (such as Ki67, cyclin D1, cleaved caspase, PARP), angiogenesis (such as microvessel density) and secretion (such as IGF-1 receptor); change from baseline of these markers at day 29 and 57.
Measured: Baseline, Day 1, 15, 29, 43, 57, 113, 169 and 225
Number of patients with AEs, SAEs at study completion
Number of patients with AEs (overall and by severity) SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: Day 253
Number of patients with electrocardiographic abnormalities and changes in electrocardiograms readings at study completion
Number of patients with ECG abnormalities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Day 253
Number of patients with laboratory abnormalities and changes in laboratory values at study completion
Number of patients with laboratory abnormalities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: Day 253
Number of patients with vital sign abnormalities and changes in vital signs at study completion
Number of patients with vital sign abnormalities and changes in vital signs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Melanoma and Merkel Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652547
- Sponsor's protocol ID
- CSOM230X2404
- Status last verified
- Mar 2016
- First submitted
- 12 Jul 2012
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01652547
- Acronym / sponsor ID
- CSOM230X2404
- Keywords
- Melanoma, Merkel cell carcinoma, Metastatic skin cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pasireotide sub-cutaneous formulation | Experimental | Drug: Pasireotide sub-cutaneous formulationPasireotide, will be administered to all patients by s.c. injection, beginning with a dose of 300 μg administered three times daily (t.i.d.) for 2 weeks. If no pasireotide-related clinically meaningful/uncontrolled grade 3 or grade 4 adverse events occur the dose will be administered to all patients at an increased dose of 600 μg t.i.d. for 2 weeks, followed by 2 weeks of 900 μg t.i.d. and followed by 2 weeks of 1200 μg t.i.d. After the 8 weeks period, patients will be kept on treatment drug (highest dose without clinically meaningful/uncontrolled AEs), switched to the corresponding pasireotide LAR dose and followed up for an extra 6 months. |
| Pasireotide long acting release | Experimental | Drug: Pasireotide lon acting release formulationAt the start of the follow-up phase patients will be switched to pasireotide LAR administered intramuscularly every 28 days by using the following conversion algorithm so that the steady state PK exposure (Cmax and Ctrough) of pasireotide will be maintained: 300 μg s.c. t.i.d. fi 20mg LAR i.m. q 28 days 600 μg s.c. t.i.d. fi 40 mg LAR i.m. q 28 days 900 μg s.c. t.i.d. fi 60 mg LAR i.m. q 28 days 1200 μg s.c. t.id. fi 80 mg LAR i.m. q 28 days In addition, all patients will keep the treatment with pasireotide s.c. during the first 2 weeks of the LAR phase. The use of s.c. dosing during the initial 2 week period following the first LAR dose provides an appropriate level of medication during the LAR nadir. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (36 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasireotide sub-cutaneous formulationPasireotide, will be administered to all patients by s.c. injection, beginning with a dose of 300 μg administered three times daily (t.i.d.) for 2 weeks. If no pasireotide-related clinically meaningful/uncontrolled grade 3 or grade 4 adverse events occur the dose will be administered to all patients at an increased dose of 600 μg t.i.d. for 2 weeks, followed by 2 weeks of 900 μg t.i.d. and followed by 2 weeks of 1200 μg t.i.d. After the 8 weeks period, patients will be kept on treatment drug (highest dose without clinically meaningful/uncontrolled AEs) , switched to the corresponding pasireotide LAR dose and followed up for an extra 6 months. | Drug | Pasireotide sub-cutaneous formulation |
| Pasireotide lon acting release formulationAt the start of the follow-up phase patients will be switched to pasireotide LAR administered intramuscularly every 28 days by using the following conversion algorithm so that the steady state PK exposure (Cmax and Ctrough) of pasireotide will be maintained: 300 μg s.c. t.i.d. fi 20mg LAR i.m. q 28 days 600 μg s.c. t.i.d. fi 40 mg LAR i.m. q 28 days 900 μg s.c. t.i.d. fi 60 mg LAR i.m. q 28 days 1200 μg s.c. t.id. fi 80 mg LAR i.m. q 28 days In addition, all patients will keep the treatment with pasireotide s.c. during the first 2 weeks of the LAR phase. The use of s.c. dosing during the initial 2 week period following the first LAR dose provides an appropriate level of medication during the LAR nadir. | Drug | Pasireotide long acting release |
Primary outcome
Number of patients with AEs, SAEs
Time frame: Week 8
Number of patients with AEs (overall and by severity) SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Number of patients with laboratory abnormalities and changes in laboratory values
Time frame: Week 8
Number of patients with laboratory abnormalities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Number of patients with electrocardiographic abnormalities and changes in electrocardiograms readings
Time frame: Week 8
Number of patients with ECG according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Number of patients with vital sign abnormalities and changes in vital signs
Time frame: Week 8
Number of patients with vital sign abnormalities according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
9 secondary outcomes
Changes in laboratory values, electrocardiograms readings, and vital signs values at study completion
Time frame: Baseline, Day 253
Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as measured by disease control rate ((DCR), (Complete Response (CR), Partial Response (PR), Stable Disease (SD))
Time frame: Baseline, Day 57, Day 113, Day 169, Day 225
PK parameters for each cycle on Day 1 (Cmax,d1 Tmax,d1, AUC0-2hr,d1), and on day 8 at steady state (Cmin,d8, Cmaxd8, Tmax,d8, Cavg,d8, AUC0-2hr,d8, ARd8)
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 85, 113, 141, 169, 197 and 225
Changes from baseline on melanoma response biomarkers (MIA, S100B) overtime and its correlation with each dose
Time frame: Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 113, 169 and 225
Changes from baseline and/or actual levels of potential response and/or secretion biomarkers over time, in repeated tumor and/or blood samples
Time frame: Baseline, Day 1, 15, 29, 43, 57, 113, 169 and 225
Number of patients with AEs, SAEs at study completion
Time frame: Day 253
Number of patients with electrocardiographic abnormalities and changes in electrocardiograms readings at study completion
Time frame: Day 253
Number of patients with laboratory abnormalities and changes in laboratory values at study completion
Time frame: Day 253
Number of patients with vital sign abnormalities and changes in vital signs at study completion
Time frame: Day 253
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Results for CSOM230X2404 on the Novartis Clinical Trial WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pasireotide sub-cutaneous formulation and Pasireotide lon acting release formulation in people with Metastatic Melanoma and Merkel Cell Carcinoma, run by Novartis Pharmaceuticals at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with AEs, SAEs (time frame: Week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.