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Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine Hydrochloride With or Without WEE1 Inhibitor AZD1775 in Treating Patients With Previously Untreated Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
Phase 1, PHASE2 trial testing AZD1775 in Metastatic Pancreatic Adenocarcinoma in 8 participants. Completed in 21 December 2022.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 19 August 2014 |
| Primary completion | 3 June 2021 |
| Estimated completion | 21 December 2022 |
| Sites | 5 locations across United States |
National Cancer Institute (NCI)
18 and older, any sex, with Metastatic Pancreatic Adenocarcinoma or Stage III Pancreatic Cancer AJCC v6 and v7. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A dose-limiting toxicity (DLT) was defined by the occurrence of any of the toxicities listed in section 5.1.5 of the protocol that are possibly, probably, or definitely related to study drug(s) within the first cycle (4 weeks = 28 days).
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Phase I - Initial Dose Level) | 2 | |
| Arm B (Phase I - Dose Level -2) | 2 |
Time frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A (Phase I - Initial D… | Arm B (Phase I - Dose Leve… |
|---|---|---|---|
| Lymphocyte count decreased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Fever | General disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Irritability | Psychiatric disorders | — | — |
| Reaction | System | Arm A (Phase I - Initial D… | Arm B (Phase I - Dose Leve… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Fever | General disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Weight loss | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Cognitive disturbance | Nervous system disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Edema limbs | General disorders | — | — |
| Pain | General disorders | — | — |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | — | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — | — |
| Periodontal disease | Gastrointestinal disorders | — | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — | — |
| Papulopustular rash | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Creatinine increased | Investigations | — | — |
| INR increased | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
Most-reported serious reactions: Lymphocyte count decreased, White blood cell decreased, Anemia, Neutrophil count decreased, Platelet count decreased, Dehydration, Thromboembolic event, Febrile neutropenia.
Data from ClinicalTrials.gov NCT02194829 adverse events section.
This partially randomized phase I/II trial studies the side effects and best dose of WEE1 inhibitor AZD1775 when given together with paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride and how well they work in treating patients with previously untreated pancreatic cancer that has spread to another place in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. WEE1 inhibitor AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride are more effective with or without WEE1 inhibitor AZD1775 in treating patients with pancreatic cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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