Solid tumours and metastatic melanoma MedDRA version: 9.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour MedDRA version: 9.1 Level: LLT Classification code 10027481 Term: Metastatic melanoma
Conditions
Interventions
Product Name: Tasidotin HCl
Pharmaceutical Form: Capsule, hard
CAS Number: 623174-20-9
Current Sponsor code: Tasidotin HCl
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Ergomed Clinical Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Have a histologically or cytologically confirmed advanced malignant solid tumor that is not amenable to surgery or radiation therapy with curative intent or that has progressed or recurred after prior standard therapy. After the MTD is determined in Part A, patients must have a diagnosis of metastatic melanoma and have lesions accessible for biopsy. (2)Systemic chemotherapy naïve patients (Part B only) (3)Have a measurable lesion according to RECIST by computerized tomography (CT) or other techniques, except for metastatic prostate cancer that may be based on prostate specific antigen (PSA) progression after previous treatment with hormonal therapy. (4)Male or female patient at least 18 years old. (5)ECOG performance status 0, 1, or 2. (6)Life expectancy of at least 12 weeks. (7)Patient has adequate organ and immune system function as indicated by the laboratory values in the protocol (8)Any chemotherapy, major surgery, or irradiation must have been completed at least 4 weeks prior to starting treatment with study drug (6 weeks for mitomycin-C or nitrosourea). Additionally, patients must have recovered from clinically significant toxicities incurred as a result of previous therapy except nail dystrophy, alopecia, grade 1 peripheral neuropathy, or local radiation therapy induced effects (i.e., impotence or incontinence). (9)Be able to comply with study procedures and follow-up examinations. (10)Not pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy. (11)Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1)Received previous treatment with tasidotin HCl or known hypersensitivity to tasidotin HCl or its analogues. (2) Known hypersensitivity to DTIC (Part B only). (3)Received radiotherapy to the only site of measurable disease. (4)Used any investigational agents during the 30 days prior to the first dose. (5)Use of any immune-suppressive agents such as the regular use of systemic corticosteroids for the part 4 weeks prior to study start (6)Has any clinical indication that may affect gastrointestinal (GI) absorption (e.g., diarrhea, ulcers, GI surgery, or other GI abnormalities). (7)Has psychiatric disorder(s) or alcohol abuse that would interfere with consent, study participation, or follow up. (8)Has uncontrolled congestive heart failure (CHF) or angina, including patients with a history of myocardial infarction within 2 months of enrollment, or patients with cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification. (8)Has a systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment. (9)Known human immunodeficiency virus (HIV) positivity. (10)Has any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo chemotherapy. (11)Patient is dependent on the investigator (e.g., family, relatives, employee…)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of Tasidotin HCl administered orally for 14 consecutive days (1 cycle) identifying the maximum tolerated dose (MTD) when administered in patients with advanced solid tumors (part A) To determine safety and tolerability of Tasidotin HCl administered orally for 10 consecutive days in combination with a standard dose and schedule of DTIC, identifying the MTD when administered in chemotherapy naïve patients with metastatic malignant melanoma (Part B);Secondary Objective: •To assess the antitumor activity of orally administered Tasidotin HCl as measured using the Response Evaluation Criteria in Solid Tumors (RECIST) in patients with advanced solid tumors •To assess clinical benefit as determined by the Investigator and defined as improvement of Eastern Cooperative Oncology Group (ECOG) performance status and improvement in serum tumor marker results (when appropriate) in the absence of an objective tumor response according to RECIST •To evaluate the pharmacokinetic characteristics of orally administered Tasidotin HCl •To determine the recommended Phase 2 dose (RP2D) To assess the antitumor activity of orally administered Tasidotin HCl in combination with DTIC as measured using the Response Evaluation Criteria in Solid Tumors (RECIST) in chemotherapy naïve patients with malignant melanoma (Part B) ;Primary end point(s): MTD as determined by the DLT(s) of Tasidotin as a single agent as well as in combination with DTIC •Antitumor activity measured by RECIST •Clinical benefit as assessed by changes in ECOG performance status and improvement in serum tumor marker results (when appropriate) •Pharmacokinetic parameters •POP enzyme activity in skin and tumor | — |
Countries
Germany, Poland
Outcome results
None listed