Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C259- Malignant neoplasm of pancreas, unspecified
Conditions
Interventions
Intervention1: PNB028: Manufacturer: PNB Vesper Life Science Pvt. Ltd., India
Pharmaceutical form: Capsule
Route of administration: Per oral.
dosing for 28 days
Control Intervention1: Placebo: Manu
Sponsors
PNB Vesper Life Science Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Colon cancer patients who have failed to 2nd line of chemotherapy or pancreatic cancer patients who have failed to 1st line of chemotherapy. Study drug can also be used as 1st line or 2nd line in colon cancer and as 1st line in pancreatic cancer if other lines of treatment are not feasible for any reason. 2. Eastern Cooperative Oncology Group (ECOG) performance status Less than or equal 2. 3. Patients with life expectancy of at least 12-24 months in colon cancer and =4 months in pancreatic cancer. 4. The serum pregnancy test at screening and urine pregnancy test before dosing on day 01 must be negative for female patients of childbearing potential. 5. Physical examination, 12-lead electrocardiogram (ECG) and vital signs without any clinically significant findings as per discretion of the investigator. 6.Clinical laboratory values within the acceptable range, unless deemed clinically not significant by the investigator. 7.Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements as evidenced by signing the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1. Patients with known brain metastasis. 2. Patients with any other malignancy other than colon cancer or pancreatic cancer. 3.History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic (other than colon and pancreatic cancer), pulmonary, immunologic, musculoskeletal, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. 4.A history of allergic response(s) to cholecystokinin receptor antagonist. 5.History of chemotherapy or radiotherapy within 2 weeks before screening. 6.History of biological therapy within 2 weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of PNB028 in patients of colon or pancreatic cancer.Timepoint: For cohort I, II, III; Visit 2 [Day 0 to Day 08], Visit 3 (Day 15 ± 1 day), Visit 4 (Day 22 ± 1 day), Visit 5 (Day 28 ± 1 day) . For cohort IV and V. Visit 2 (Day 01), Visit 3 (Day 04 ± 1), Visit 4 (Day 08 ± 1), Visit 5 (Day 15 ± 1), Visit 6 (Day 22 ± 1), Visit 7 (Day 28 ± 1), Visit 8 (Day 42 ± 1), Visit 9 (Day 56 ± 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess pharmacokinetic of PNB028 in patients of colon or pancreatic cancer.Timepoint: In cohort I, II, and III: Visit 2 (check-in), Visit 3 (Day 15 ± 1), Visit 4 (Day 22 ± 1), Visit 5 (Day 28 ± 1) at the time of check-in. In cohort IV and V: Visit 2 (Day 1), Visit 3 (Day 4 ± 1), Visit 4 (Day 8 ± 1), Visit 5 (Day 15 ± 1), Visit 6 (Day 22 ± 1), Visit 7 (Day 28 ± 1) and also in Visit 8 (Day 42 ± 1) and Visit 9 (Day 56 ± 1) if applicable. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Ltd
Outcome results
None listed