Clinical trial · Interventional
PR-104 and Docetaxel or Gemcitabine in Treating Patients With Solid Tumors
A Phase Ib, Multi-Center, Open-Label, Dose Escalation Trial of Intravenous PR-104 Given in Combination With Docetaxel or Gemcitabine in Subjects With Solid Tumors
- 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: Drugs used in chemotherapy, such as PR-104, docetaxel, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with docetaxel or gemcitabine in treating patients with solid tumors.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| PR-104 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose of PR-104
Secondary outcomes (5)
- measure
- Safety of PR-104 as measured by CTCAE v3.0 criteria
- measure
- Dose-limiting toxicity of PR-104
- measure
- Pharmacokinetics of PR-104 and its alcohol metabolite in the blood
- measure
- Pharmacokinetics of gemcitabine and docetaxel in the presence of PR-104
- measure
- Antitumor activity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor malignancy * Treatment with either docetaxel or gemcitabine hydrochloride in combination with an investigational agent is reasonable * Measurable or evaluable disease PATIENT CHARACTERISTICS: * ECOG performance status of 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL (red blood cell transfusion allowed) * Bilirubin normal * ALT and AST ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 1.5 times ULN * PT/INR or aPTT ≤ 1.1 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after completion of study therapy * No evidence of any other significant medical disorder, including uncontrolled infection or infection requiring a concurrent parenteral antibiotic, or laboratory finding that, in the opinion of the investigator, would preclude study compliance * No known HIV positivity * No hepatitis B surface antigen positivity * No hepatitis C positivity with abnormal liver function test PRIOR CONCURRENT THERAPY: * No prior radiotherapy to \> 25% of bone marrow * No prior high-dose chemotherapy (including conditioning for either myeloablative or nonmyeloablative transplantation) * No more than 3 prior chemotherapy regimens * More than 4 weeks since prior major surgery * More than 4 weeks since prior investigational or traditional anticancer therapy (including radiotherapy) (6 weeks for nitrosoureas and mitomycin C) * The following medications/treatments are not permitted during the trial: * Any other licensed or investigational anticancer treatment * Prophylactic hematopoietic growth factors * Irradiation therapy (palliative or therapeutic) unless given in the absence of tumor progression * Concurrent systemic steroids allowed provided the patient is on a stable dose for ≥ 2 weeks prior to study treatment * Concurrent androgen-deprivation therapy allowed
References
Publications (1)
- DERIVEDMcKeage MJ, Jameson MB, Ramanathan RK, Rajendran J, Gu Y, Wilson WR, Melink TJ, Tchekmedyian NS. PR-104 a bioreductive pre-prodrug combined with gemcitabine or docetaxel in a phase Ib study of patients with advanced solid tumours. BMC Cancer. 2012 Oct 25;12:496. doi: 10.1186/1471-2407-12-496. PMID 23098625