Advanced Solid Tumours
Conditions
Brief summary
This is a study for extended use of ModraDoc006/r in patients with advanced solid tumours, available after completed treatment in one of the phase I trials with ModraDoc006/r. The primary goal is to explore the safety of extended use.
Detailed description
This is an open label extended use programme, designed to make extended use treatment with weekly ModraDoc006/r available for patients who completed treatment in one of the phase I trials with ModraDoc006/r, who might have clinical benefit of continued treatment with the oral docetaxel formulation. Patients will receive oral docetaxel (as ModraDoc006 10 mg tablets) and ritonavir (100 mg tablet) once- or bi-daily, once a week in a fasted condition. Treatment can be continued weekly as long as the patient experiences clinical benefit from the treatment as judged by the treating oncologist, unless unacceptable toxicity despite dose modifications and supportive measures occurs.
Interventions
DRUGModraDoc006/r
Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets
Sponsors
Modra Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After completion of a phase 1 trial with ModraDoc006/r, patients are able to continue weekly treatment with oral docetaxel (ModraDoc006) in combination with ritonavir, for as long as safe clinical benefit from the treatment is experienced, as judged by the treating oncologist.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histological or cytological proof of cancer 2. Patients who might benefit from a weekly (oral) docetaxel regime as judged by the treating oncologist. 3. Patients who received treatment with ModraDoc006/r with acceptable safety (as judged by the PI; for criteria see below in section 3 of
Exclusion criteria
) in phase I trials with ModraDoc006/r, including (but not limited to) the N15FED (food-interaction study), N16AED (absorption-excretion study), N16DOL (normal or impaired liver function). A maximum delay of 21 days between the last dose in the previous phase I trial and the first dose in the N17DEX is allowed. 4. Age ≥ 18 years 5. WHO performance status of 0, 1 or 2; 6. Minimal acceptable laboratory values defined as: 1. ANC of ≥ 1.5 x 109 /L 2. Platelet count of ≥ 100 x 109 /L 3. Renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula) 4. Hepatic function as defined by serum bilirubin ≤ 2 x ULN, ALAT and ASAT ≤ 5.0 x ULN, except for patients who have been treated in the N16DOL study. 7. Negative pregnancy test (urine/serum) for female patients with childbearing potential, assessed at the screening visit of the previous phase I trial with ModraDoc006/r. 8. Able and willing to swallow oral medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The hematological and non-hematological toxicity profile of oral docetaxel in combination with ritonavir | Safety and tolerance will be evaluated during the complete study treatment until 28 days after the last intake, using the CTCAE v.4.03 grading system | The number of CTCAE v.4.03 grade 3-4 toxicities during treatment with ModraDoc006/r |
Countries
Netherlands
Outcome results
None listed