ModraDoc006/r in Patients With Breast Cancer

NCT03890744 | Completed Phase 2

• 1 other identifier: M18DMB
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 4

Brief Summary

This is a multicenter phase IIa study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with recurrent or metastatic HER-2 negative breast cancer, that are suitable for treatment with a taxane as 1st-3rd line of therapy.

Conditions

Metastatic Breast Cancer; Recurrent Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The objective response rate (ORR)

  Evaluation of objective response rate that will be observed as measured by RECIST v1.1 criteria, in patients with recurrent or metastatic HER2 negative breast cancer after treatment with ModraDoc006/r

  From baseline through study completion, an average of 1 year

Secondary Outcomes (2)

• The number of CTCAE v.4.03 toxicities during treatment with ModraDoc006/r

  Evaluation of toxicities during the complete study treatment until 28 days after the last intake, using the CTCAEv4.03 grading system

• The activity data on progression-free survival (PFS) of ModraDoc006/r

  From baseline through study completion, an average of 1 year

Other Outcomes (1)

• The number of CTCAE v.4.03 toxicities during treatment with ModraDoc006/r in a population of frail patients

  Evaluation of toxicities during the complete study treatment until 28 days after the last intake, using the CTCAEv4.03 grading system

Study Arms (1)

ModraDoc006/r

EXPERIMENTAL

Weekly ModraDoc006/r treatment as ModraDoc006 (oral docetaxel) 10mg tablets combined with ritonavir 100mg tablets

Drug: ModraDoc006/r

Interventions

ModraDoc006/r DRUG

Treatment with twice daily once weekly (BIDW) ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets

Also known as: oral docetaxel formulation

ModraDoc006/r

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written informed consent and to comply with the protocol
• Histologically- or cytologically confirmed diagnosis of recurrent or metastatic HER-2 negative breast cancer
• Female of age 18 years or above
• Patients who are eligible to receive a taxane as monotherapy as 1st-3rd line of therapy for recurrent or metastatic breast cancer. A maximum of two previous lines of chemotherapy is allowed (including experimental i.e. non-registered chemotherapy alone or in combination). Re-treatment with one of the same drugs after treatment interruption for reasons of patient preference and/or progression of disease counts as a new treatment
• WHO performance status of 0, 1 or 2 (Appendix II)
• Estimated life expectancy of at least 12 weeks
• Resolution of toxicity of prior therapy to \< grade 2 (except for alopecia and transaminases in case of liver metastases) as defined by CTCAE v5.0 (Appendix III)
• Evidence of measurable disease present at baseline as defined by RECIST v1.1
• Able and willing to swallow oral medication
• Able and willing to undergo radiologic scans (CT scan, or MRI if CT is contraindicated)
• All patients of childbearing potential must have a negative high sensitive pregnancy test at screening (urine/serum) and agree to use highly effective method for contraception from time of signing Informed Consent until at least 12 weeks after the last administration of study drug
• Laboratory criteria:
• Platelet count ≥ 100 x 109 /L
• Haemoglobin ≥ 6.0 mmol/L or 9.67 g/dL
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109 /L

You may not qualify if:

• Systemic chemotherapy or radiation therapy within the last 4 weeks, endocrine based therapy and CDK4/6 inhibitors within 1 week prior to first dose of ModraDoc006/r. Single dose palliative radiation for pain relieve is allowed until one week prior to start with ModraDoc006/r (these lesions are not to be included as target lesions)
• Any treatment with investigational drugs (or investigational device) within 21 days prior to receiving the first dose of ModraDoc006/r
• Previous treatment with a taxane for recurrent or metastatic breast cancer
• Major surgical procedures within 21 days prior to providing informed consent
• Active acute or chronic infection, which is not controlled by appropriate medication (at the discretion of the treating physician)
• Uncontrolled or significant cardiovascular disease defined as New York Heart Association Classification III or IV
• Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the Investigator would impair study compliance
• Any medical condition that in the opinion of the Investigator would contra-indicate or preclude participation within the clinical trial, or would put the patient at high risk for treatment-related complications
• Previous malignancies within the last three years other than breast carcinoma, except successfully treated squamous/basal cell carcinoma of the skin, superficial bladder cancer, and in situ carcinoma of the cervix
• Patients with symptomatic brain metastases. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anticonvulsant therapy for at least 6 weeks are allowed to enrol. Radiotherapy for brain metastasis must have been completed at least 6 weeks prior to start of study treatment. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive anti-epileptic drugs or corticosteroid treatment indicated for brain metastasis
• Patients with confirmed leptomeningeal metastases
• Women who are pregnant or breast feeding
• Known positivity for Human Immunodeficiency Virus HIV-1 or HIV-2 type
• Patients with known active infection of hepatitis B, C, or E (patients who are anti-HBC positive but HBsAg negative are eligible to participate in this study)
• Bowel obstructions or motility disorders that may influence the resorption of drugs as judged by the Investigator

Sponsors & Collaborators

• Modra Pharmaceuticals: lead

Study Sites (4)

Institut Jules Bordet

Brussels, B-1000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Hospital Quiron Pozuelo

Madrid, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marianne Keessen

  Modra Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 14 evaluable patients will be treated in the first stage (Stage A) of this Simon two-stage minimax designed trial. If 0 or ≥ 2 objective responses at week 8 (with confirmation at week 12) are observed in Stage A, no further patients will be enrolled. If 1 objective response is observed, an additional 10 patients with recurrent or metastatic HER-2 negative breast cancer will be included in the second stage (Stage B).

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: March 26, 2019
• Study Start: January 30, 2019
• Primary Completion: February 13, 2020
• Study Completion: November 9, 2020
• Last Updated: October 19, 2021

Record last verified: 2019-03

Locations

ES (1); BE (2); DK (1)