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NCT03147378
Food Effect Study of ModraDoc006 in Combination With Ritonavir
Phase 1 trial testing ModraDoc006/r in Solid Tumor, Adult in 18 participants. Completed in 4 April 2018.
4 April 2018
Quick facts
| Lead sponsor | Modra Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 10 May 2017 |
| Primary completion | 4 April 2018 |
| Estimated completion | 4 April 2018 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- ModraDoc006/r — full drug profile →
Conditions studied
- Solid Tumor, Adult — all drugs for Solid Tumor, Adult →
Sponsor
Modra Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate the effect of food on the pharmacokinetics of ModraDoc006 in combination with ritonavir, in an open-label, cross-over design. Patients will be randomized into two treatment groups receiving ModraDoc006/r week 1 under fasting and week 2 under fed condition, or vice versa.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3 -
Energy metabolism in health and diseases.
Liu H, Wang S, Wang J, Guo X, et al · · 2025 · cited 178× · PMID 39966374 · DOI 10.1038/s41392-025-02141-x -
Effect of Food on the Pharmacokinetics of the Oral Docetaxel Tablet Formulation ModraDoc006 Combined with Ritonavir (ModraDoc006/r) in Patients with Advanced Solid Tumours.
Vermunt MAC, de Weger VA, Janssen JM, Lopez-Yurda MI, et al · · 2021 · cited 2× · PMID 33464545 · DOI 10.1007/s40268-020-00336-x
Verify or expand the search:
- PubMed search for NCT03147378
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ModraDoc006/r
Trials testing the same drug.
- NCT04028388 — ModraDoc006/r vs Docetaxel IV in Metastatic Prostate Cancer · Phase 2 · completed
- NCT03890744 — ModraDoc006/r in Patients With Breast Cancer · Phase 2 · completed
- NCT03150368 — Extended Use of ModraDoc006/r · Phase 1 · completed
- NCT03136640 — ModraDoc006/r in Metastatic Castration-resistant Prostate Cancer · Phase 1 · completed
Other recruiting trials for Solid Tumor, Adult
Currently open trials in the same condition.
- NCT07139990 — Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM) · Phase 1 · recruiting
- NCT06398418 — R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients · Phase 1 · recruiting
- NCT06682793 — A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumor · Phase 1, PHASE2 · recruiting
- NCT07137195 — Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Hebei) · NA · active not recruiting
- NCT06714617 — Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
Other Modra Pharmaceuticals trials
Trials by the same sponsor.
- NCT04028388 — ModraDoc006/r vs Docetaxel IV in Metastatic Prostate Cancer · Phase 2 · completed
- NCT03890744 — ModraDoc006/r in Patients With Breast Cancer · Phase 2 · completed
- NCT03150368 — Extended Use of ModraDoc006/r · Phase 1 · completed
- NCT03136640 — ModraDoc006/r in Metastatic Castration-resistant Prostate Cancer · Phase 1 · completed
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 NCT03147378 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Modra Pharmaceuticals
- Last refreshed: 19 October 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/NCT03147378.
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