Safety of continued use of oral docetaxel in patients with advanced solid types of cancer

Phase 1

• Conditions: Advanced solid malignancies; MedDRA version: 19.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000347-41-NL
• Lead Sponsor: Modra Pharmaceuticals BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-22
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

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 inegibility 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:
a. ANC of = 1.5 x 109 /L
b. Platelet count of = 100 x 109 /L
c. Renal function as defined by serum creatinine equal or lower than 3.0 x ULN
d. Hepatic function as defined by serum bilirubin equal or lower than 5.0 x ULN, ALAT and ASAT equal or lower than 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 screeningsvisit for the previous phase I trial with ModraDoc006/r treatment
8. Able and willing to swallow oral medication

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Concomitant use of MDR and CYP3A modulating drugs such as Ca+-entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications; other protease inhibitors, (non) nucleoside analoga, St. Johns wort or macrolide antibiotics.
2. Symptomatic brain metastases or leptomeningeal metastases. Patients with brain metastases are allowed if they received adequate treatment, are asymptomatic in the absence of corticosteroid therapy and anticonvulsant therapy for at least 6 weeks. Radiotherapy for brain metastases must have been completed at least 4 weeks prior to start of study treatment.
3. Clinically significant safety issues during previous therapy with ModraDoc006/r as judged by the PI, which cannot be solved by dose reduction and/or treatment delay.
4. Unreliable contraceptive methods. Both men and women using ModraDoc006/r must agree to use a reliable contraceptive method throughout the treatment
5. Oncolytic therapy or any treatment with investigational drugs other than ModraDoc006/r between the completion of the phase I trial with ModraDoc006/r and the start of extended use of ModraDoc006/r Palliative limited radiation is allowed, but must have been completed at least 4 weeks prior to start of extended use.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the safety of 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.;Secondary Objective: not applicable;Primary end point(s): The safety of 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.;Timepoint(s) of evaluation of this end point: Ongoing evaluation during the complete duration of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable