Pazopanib dose hunt in frail seniors halted early
NCT ID NCT01642017
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 1 study tested the cancer drug pazopanib in 18 frail elderly patients (aged 75+) with metastatic cancers like kidney, lung, or breast cancer. The goal was to find the highest safe dose by starting at 400 mg daily and increasing if tolerated. The study was terminated early, so the full planned enrollment of 30 patients was not reached.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pazopanib (a targeted cancer drug taken as a pill)
- What this could lead to
- If successful, this could help doctors find a safer dose of pazopanib for frail elderly patients with advanced cancer, potentially offering a treatment option where few exist.
- What could go wrong
- This is a very early, small phase 1 trial that was terminated early, so results are limited. The drug may still cause significant side effects, and it is not a cure—patients take it until the disease gets worse.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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18 people
The number who actually took part.
- Started
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Nov 2012
- Finished
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Mar 2018
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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75 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up. 2. Age ≥ to 75 years old 3. Patient with metastatic cancer among renal cell carcinoma, non small cell lung cancer, pancreatic neuroendocrine cancer, sarcoma , ovarian cancer , thyroid cancer, bladder cancer or breast cancers, who cannot receive any treatment with curative intent. 4. WHO PS ≤ 2, 5. Life expectancy ≥ 3 months, 6. Group 2 (vulnerable) according to SIOG classification, 7. Adequate organ system function as defined in provided Table Exclusion Criteria: 1. Patient with a history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localized prostate carcinoma with PSA \<1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, and who is deemed at low risk for recurrence by his/her treating physician, 2. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. 3. Criteria of group 3 according to SIOG classification, 4. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to: •Active peptic ulcer disease •Known intraluminal metastatic lesion/s with risk of bleeding •Inflammatory bowel disease (e.g. ulcerative colitis, crohn's disease), or other gastrointestinal conditions with increased risk of perforation •History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment. 5. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: •Malabsorption syndrome •Major resection of the stomach or small bowel. 6. Presence of uncontrolled infection. 7. Corrected QT interval (QTc) \> 480 msecs using Bazett's formula 8. Anti-coagulants treatment (preventive or curative) 9. History of any one or more of the following cardiovascular conditions within the past 6 months: • Cardiac angioplasty or stenting • Myocardial infarction • Unstable angina • Coronary artery bypass graft surgery * Symptomatic peripheral vascular disease * Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) 10. Poorly controlled hypertension 11. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. 12. Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer 13. Evidence of active bleeding or bleeding diathesis. 14 Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels 15\. Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks of first dose of study drug. 16\. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. 17\. Unable or unwilling to discontinue use of prohibited medications list in Appendix 7 for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study 18\. Treatment with any of the following anti-cancer therapies: * radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR * chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib 19\. Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity, except alopecia. 20\. Patient not affiliated with social system in France. 21\. Patient deprived of liberty or under guardianship
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre François BACLESSE
Caen, 14076, France
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Centre Léon BERARD
Lyon, 69008, France
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Hôpital Saint André
Bordeaux, 33075, France
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Institut Claudius REGAUD
Toulouse, 31052, France
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