Clinical trial · Interventional
Efavirenz as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
A Phase II Trial to Assess the Efficacy of Efavirenz as Second-line Monotherapy for the Treatment of Advanced Pancreatic Adenocarcinomas.
NCT00964171CI-TRIAL-00094232PANTERcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well efavirenz works as second-line therapy in treating patients with metastatic pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Efavirenz 600mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Efavirenz
- description
- Efavirenz will be provided by the sponsor as follows: capsule of efavirenz 200 mg. A bottle contains 90 capsules. Investigator will dispense efavirenz to the patients according to the dose adjustment. Each patient will receive efavirenz 600 mg/day until morphological progression. Study drug will be taken every day by oral route at bedtime and in fast condition (1-2 hours far from dinner).
- interventionNames
- Drug: Efavirenz 600mg
Primary outcomes (1)
- measure
- Percentage of Patients in Non-progression at 2 Months
- timeFrame
- 2 months
- description
- Non-progression is defined as partial response, complete response or stable disease according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).Stable disease is defined as no decrease or increase sufficient to qualify as partial response or progression with reference to SLD since the start of treatment. Radiologic assessment was carried out every 8 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas * No other histological types * Radiologically confirmed metastatic disease in a non-irradiated area * Measurable disease according to RECIST criteria * Must have exhausted first-line gemcitabine hydrochloride chemotherapy * No CNS metastases PATIENT CHARACTERISTICS: * WHO performance status (PS) 0-2 OR Karnofsky PS 70-100% * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine ≤ 1.25 times upper limit of normal * Alkaline phosphatase \< 5 times normal * Bilirubin \< 3 times normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Has French Social Security in compliance with the French law relating to biomedical research * Able to comply with study treatment and follow-up * No severe renal failure * No severe hepatic impairment * No known hypersensitivity to the study drug and its excipients * No depression with a total score of ≥ 13 on the Hospital Anxiety and Depression (HAD) scale * No active diarrhea that may affect the ability to absorb the study drug * No other cancer within the past 5 years except carcinoma in situ of the cervix or basal cell carcinoma of the skin * No geographical, psychiatric, social, or psychological reason that would preclude compliance with study procedures PRIOR CONCURRENT THERAPY: * Recovered from all prior anticancer therapy * More than 30 days since prior investigational drugs and/or participation in a clinical trial * Prior adjuvant chemotherapy (one-line only) and/or radiotherapy allowed * No prior enrollment on this study * No prior treatment acting on the signal transduction pathway * No prior yellow fever vaccine * No other concurrent second-line therapy * No concurrent terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, rye alkaloids, voriconazole, or St. John wort (Hypericum perforatum)
References
Publications (0)
Data not yet available
No reference posted for this study.