Status:
COMPLETED
Safety and Tolerability of AP 12009, Administered I.V. in Patients With Advanced Tumors Known to Overproduce TGF-beta-2
Lead Sponsor:
Isarna Therapeutics GmbH
Conditions:
Pancreatic Neoplasms
Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
In this national Phase I dose-escalation study the safety and tolerability of AP 12009 is evaluated in adult patients with advanced tumors known to overproduce TGF-β2, who are not or no longer amenabl...
Detailed Description
The purpose of this dose-finding study is to evaluate the safety and tolerability of AP 12009. Two fixed dose-escalation schemes with predefined steps and increasing increments have been selected to d...
Eligibility Criteria
Inclusion
- Written informed consent.
- Age: 18-75 years.
- Male or non-pregnant, non-lactating female.
- a.Pancreatic cancer: Histologically or cytologically confirmed diagnosis, stage IVA or IVB (AJCC, 1997).
- b. Melanoma: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC).
- c. Colorectal cancer: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC), excluded from the last cohort.
- Patient is not or no longer amenable to established forms of therapy.
- At least one measurable lesion.
- Karnofsky performance status of at least 80%.
- Recovery from acute toxicity caused by any previous therapy.
- Adequate organ function as assessed by the following laboratory values:
- Serum creatinine and urea \< 2 times the upper limit of normal (ULN).
- ALT and AST \< 3 ULN (in case of a liver metastasis: \< 5x ULN); alkaline phosphatase \< 3 ULN; and bilirubin \< 2.5 mg/dL.
- Prothrombin time \< 1.5 INR and PTT \< 1.5 times the upper limit of normal.
- Hemoglobin \> 9 g/dL.
- Platelets \> 100 x 10E9/L.
- WBC \> 3.0 x 10E9/L.
- Absolute Neutrophil Count (ANC) \> 1.5 x 10E9/L.
Exclusion
- Patient unable to comply with the protocol regulations.
- Pregnant or lactating female.
- Antitumor radiation therapy within 12 weeks, tumor surgery within 4 weeks or any other therapy with established antitumor effects within 2 weeks prior to study entry.
- The patient takes or is likely to need other prohibited concomitant medication. Administration of corticosteroids should be strictly avoided during the course of the study.
- Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.
- History of brain metastases. In the case of suspected brain metastases a CT scan of the skull will be performed (not mandatory in asymptomatic patients).
- Clinically significant cardiovascular abnormalities such as refractory hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or a myocardial infarction within 6 months prior to treatment.
- Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs.
- An active infection with HIV, HBV, or HCV.
- Clinically significant acute viral, bacterial, or fungal infection.
- Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment.
- History of allergies to reagents used in this study.
- Drug abuse or extensive use of alcohol.
- Significant psychiatric disorders/ legal incapacity or limited legal capacity.
- History of Long QT Syndrome or QTc time ≥ 480 msec in screening/baseline ECGs. The average QTc time is to be calculated from three separate ECGs performed prior to start of infusion: two ECGs performed at Screening/Baseline (with a minimum 1-hour interval in between) and one performed within 1 hour prior to start of infusion.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00844064
Start Date
January 1 2005
End Date
November 1 2011
Last Update
February 15 2019
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsmedizin Berlin Charité
Berlin, Germany, 10117
2
Universitätsklinik und Poliklinik für Innere Medizin I
Halle, Germany, 06120
3
Hautklinik der Ruprecht-Karls-Universität Heidelberg
Heidelberg, Germany, 69115
4
Universitätsklinikum Schleswig-Holstein
Kiel, Germany, 24105