A clinical trial to study the safety and efficacy of ON 01910.Na in combination with gemcitabine in patients with previously untreated Metastatic pancreatic cancer
- Conditions
- Previously Untreated Metastatic Pancreatic Cancer
- Registration Number
- CTRI/2011/06/001837
- Lead Sponsor
- Onconova Therapeutics Inc
- Brief Summary
This study is a randomized, controlled study for comparing the safety and efficacy of Gemcitabine alone versus ON 01910.NA in combination with Gemcitabine previously untreated Metastatic pancreatic cancer. The study will be conducted at three sites in India and also conducted in USA. The primary objective of study is to compare the Overall survival in two arms and Secondary objectives are to compare the Progression Free Survival time, Objective Response Rate, Safety and Quality of life in two arms. Additional secondary objectives are Pharmacokinetics in treatment group and Biomarker analysis on archival tissue.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 400
- Patients at least 18 years old with histopathologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
- Patients must have received no prior chemotherapy for pancreatic cancer.
- Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan; measurable lymph nodes must be ≥ 15 mm in the short axis.
- ECOG Performance Status of 0, 1, or 2.
- Patients must have adequate renal function and serum creatinine ≤2.0 mg/dL, with a minimum calculated glomerular filtration rate (GFR) of 40 mL/min.
- Patients must have adequate liver function as defined by total bilirubin ≤ 2.0 mg/dL and transaminase levels no higher than 3.0 times the institutions upper limit of normal (ULN).
- Patients with hepatic metastases may have transaminase levels of up to 5.0 times the ULN.
- All patients must have a serum albumin ≥ 3.0 g/dL.
- Patients must have adequate bone marrow (BM) function as defined by a granulocyte count ≥ 1,500/mm3, a platelet count ≥ 100,000/mm3, and hemoglobin 9 g/dL.
- Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ [DCIS] breast disease).
- Adequate contraceptive regimen (including prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study for female patients of reproductive potential or female partners of male patients.
- Male patients with female partners with reproductive potential will utilize birth control methods (e.g., condom use) while participating in this trial; 11.Female patient with reproductive potential must have a negative urine beta human chorionic gonadotropin pregnancy test at Screening.
- 12.Willing to adhere to the prohibitions and restrictions specified in this protocol.
- 13.Patient must have signed an informed consent document.
- Patients with any of the following will not be enrolled in the study: 1.
- Patients with unresectable locally advanced disease without evidence of disease elsewhere; 2.
- Life expectancy of less than 12 weeks; 3.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension or seizure disorder; 4.
- Active infection not adequately responding to appropriate therapy.
- Symptomatic or clinically evident ascites.
- Serum sodium less than 130 mEq/L or conditions that may predispose patients to hyponatremia (e.g., previous syndrome of inappropriate antidiuretic hormone hypersecretion [SIADH], chronic diuretic use, etc.) 7.
- Female patients who are pregnant or lactating.
- Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start.
- Evidence of brain metastases.
- A CT scan or magnetic resonance imaging (MRI) of the brain should be obtained in patients with symptoms suggestive of brain metastases; 10.
- Any concurrent administration and/or prior administration within 4 weeks of the first dose of study drug, of an investigational agent, chemotherapy, radiotherapy, or immunotherapy.
- Psychiatric illness/social situations that would limit the patients ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures (e.g., drug addition, chronic non-compliance, etc.).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival Time This is the time from randomization to death of patient from any cause.
- Secondary Outcome Measures
Name Time Method ON 01910.Na Population Pharmacokinetics for all patients in Arm A at pre-dose, 1 hour after starting the ON 01910.Na infusion, and just before the end of the ON 01910.Na infusion Full ON 01910.Na and gemcitabine pharmacokinetics in a subset of 10 patients in the combined treatment group only •predose,i.e.,before starting gemcitabine infusion Biomarker analysis At the time of screening
Trial Locations
- Locations (12)
Amrita Institute of Medical Sciences and Research Centre, Cochin
🇮🇳Ernakulam, KERALA, India
Basavatarakam Indo-American Cancer Hospital & Research Institute, Hyderabad
🇮🇳Hyderabad, ANDHRA PRADESH, India
Chittaranjan National Cancer Institute
🇮🇳Kolkata, WEST BENGAL, India
Dayanand Medical College and Hospital
🇮🇳Ludhiana, PUNJAB, India
Grant Medical Foundation, Ruby Hall Clinic
🇮🇳Pune, MAHARASHTRA, India
Jaslok Hospital & Research Centre
🇮🇳Mumbai, MAHARASHTRA, India
Lifeline Multispeciality Hospitals
🇮🇳Chennai, TAMIL NADU, India
Mahatma Gandhi Cancer Hospital & Research Institute
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Regional Cancer Centre, Thiruvananthapuram
🇮🇳Thiruvananthapuram, KERALA, India
Shatabdi Superspeciality Hospital, Nashik
🇮🇳Nashik, MAHARASHTRA, India
Scroll for more (2 remaining)Amrita Institute of Medical Sciences and Research Centre, Cochin🇮🇳Ernakulam, KERALA, IndiaDr Pavithran KPrincipal investigator91-9895367090pavithrank@aims.amrita.edu