Clinical trial · Interventional
Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)
Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients with non-small-cell lung cancer who haven't responded to first-line therapies (platinum-based drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months after starting docetaxel treatment. The PR88202 study has been designed to compare two different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which is more effective against the cancer. It is hoped that the combination of PI-88 with docetaxel will allow patients to extend the time it takes for their disease to progress, and also to improve their quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| PI-88 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
Secondary outcomes (4)
- measure
- Time to progression
- measure
- Response rate
- measure
- Quality of life
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed stage IIIb or IV NSCLC that has progressed during or after first-line treatment * measurable disease by spiral CT chest scan, as defined in RECIST criteria * performance status 0-1 (ECOG) * life expectancy at least 2 months * adequate hemopoietic, renal and hepatic function Exclusion Criteria: * current symptomatic central nervous system (CNS) involvement * prior or co-existent malignancies * significant non-malignant disease * acute or chronic gastrointestinal (GI) bleeding in last two years * inflammatory bowel disease * abnormal bleeding tendency * patients at risk of bleeding due to open wounds or planned surgery * clinically significant hemoptysis within the past 4 weeks * bilirubin \> upper limit of normal (ULN) * ALT and AST \> 2.5 times ULN, or \> 1.5 times ULN if alkaline phosphatase \> 2.5 times ULN * alkaline phosphatase \> 5 times ULN, unless patient has bone metastases * myocardial infarction, stroke or congestive heart failure within last 3 months * prior treatment with docetaxel * concomitant treatment with aspirin (\>100 mg/day), NSAIDs (except selective COX-2 inhibitors, warfarin (\>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4 inhibitors * women who are pregnant or breast-feeding * women of child-bearing potential not using adequate contraception * history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin * history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease * allergy to polysorbate 80 (component of Taxotere®) * uncontrolled or serious infection in last 4 weeks
References
Publications (0)
Data not yet available