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NCT03607149: PKAPIR
Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies
Phase 4 trial testing Pemetrexed in Non-small Cell Lung Cancer in 11 participants. Completed in 20 February 2020.
20 February 2020
Quick facts
| Lead sponsor | Centre Georges Francois Leclerc |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 6 April 2017 |
| Primary completion | 20 February 2020 |
| Estimated completion | 20 February 2020 |
| Sites | 3 locations across France |
Drugs / interventions tested
- Pemetrexed — full drug profile →
Conditions studied
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
Sponsor
Centre Georges Francois Leclerc — full company profile →
Who can join
18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs. The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03607149
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other recruiting trials for Non-small Cell Lung Cancer
Currently open trials in the same condition.
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Other Centre Georges Francois Leclerc trials
Trials by the same sponsor.
- NCT07575854 — A Study of Selective Internal Radiation Therapy for the Management of Chemotherapy-induced Thrombocytopenia With Splenom · NA · not yet recruiting
- NCT07413627 — A Study Evaluating the Contribution of Non-Coplanar Beam Arrangement in Reducing Toxicity in Radiotherapy for Upper Aero · NA · not yet recruiting
- NCT07376512 — Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis · not yet recruiting
- NCT07093593 — Emergence of Bacterial Resistance to Antibiotics in the Digestive Microbiota of Patients Treated With Anticancer Drugs · NA · not yet recruiting
- NCT06944548 — Evaluation of the Effect of Adapted Physical Activity on the Modification of Lipid Metabolism During Chemotherapy for Me · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03607149 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Georges Francois Leclerc
- Last refreshed: 24 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03607149.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing