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Metastatic Breast CancerPhase 2NCT03890744

ModraDoc006/r in Patients With Breast Cancer

A Phase 2 study testing ModraDoc006/r in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Modra Pharmaceuticals at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
ModraDoc006/r
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesin 3 countries
Study dates
30 Jan 2019to 9 Nov 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Total bilirubin ≤ 1.5 x ULN, except for patients with familial bilirubinaemia (Gilbert's disease)
  • Serum ASAT and ALAT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases)
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula or MDRD [Modification of Diet in Renal Disease])

Who cannot join

  • 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
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  • 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
  • Patients with unstable ascites, defined as need for palliative paracentesis or presence of a permanent peritoneal drain in the past 4 weeks prior to first dose of ModraDoc006/r. Enrolment in patients with peritonitis carcinomatosa and malignant ascites is allowed if there is no clinical and/or radiological known or suspected motility disorder within the 4 weeks prior to the first dose of ModraDoc006/r
  • Concomitant use of MDR, MRP, OATP1B1, OATP1B3 and CYP3A modulating drugs such as Ca+- entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, and grapefruit juice, concomitant use of HIV medications, other protease inhibitors, (non) nucleoside analogues, or St. John's wort (see section 5.8). These need to have been stopped at least 5 times the terminal half-life (according to Summary of Product Characteristics (SPC)) or 7 days, whichever is longest, in order to prevent interaction with the drug. Tamoxifen and megestrol need to be stopped only 1 week prior to start of the first dose of ModraDoc006/r
  • Legal incapacity

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Belgium2 sites

  • Institut Jules Bordet

    Brussels, B-1000

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

Denmark1 site

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Spain1 site

  • Hospital Quiron Pozuelo

    Madrid

Other trials in Spain

About this study

Official title: A Multicentre Phase IIa Study to Evaluate the Efficacy and Tolerability of ModraDoc006/r in Patients With Recurrent or Metastatic HER-2 Negative Breast Cancer, Suitable for Treatment With a Taxane

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.

Read the detailed description

This is a phase IIa, multicentre, two-stage, single-arm, clinical study with the primary objective is to determine the efficacy of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with recurrent or metastatic HER-2 negative breast cancer, as measured by RECIST v1.1 criteria of objective response rate (ORR). To this aim, a Simon two-stage minimax design will be used, in which 14 evaluable patients will be treated in the first stage (Stage A). 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).

All patients will be treated with ModraDoc006/r, given as oral tablets twice daily once weekly (BIDW).

Patients will be radiologically assessed at week 8 and 12 by CT scan (or MRI if CT is contraindicated), and may continue to receive study medication with ongoing radiological scans every 6 weeks until disease progression (according to RECIST v1.1), unacceptable toxicity, or discontinuation for any other reason.

Furthermore, the safety and tolerability of ModraDoc006/r in the target population will be assessed. Additionally, as metastatic breast cancer may occur at older age, often coinciding with other non-malignant diseases and co-medications, this protocol investigates whether ModraDoc006/r can be applied safely in these (frail) patients.

Being tested
ModraDoc006/r
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ModraDoc006/rDrug

    Also called oral docetaxel formulation

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

Study groups in NCT03890744
Study groupRoleWhat they receive
ModraDoc006/rExperimentalWeekly ModraDoc006/r treatment as ModraDoc006 (oral docetaxel) 10mg tablets combined with ritonavir 100mg tablets
Receives: Drug: ModraDoc006/r

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From baseline through study completion, an average of 1 year

Secondary outcomes (2)

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

    The hematological and non-hematological toxicity profile of ModraDoc006/r will be assessed by clinical and lab evaluation and evaluated according to CTCAE v.4.03

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

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

    Evaluation of progression free interval (PFS) that will be observed as measured by RECIST v1.1 criteria, in patients with recurrent or metastatic HER2 negative breast cancer during and after treatment with ModraDoc006/r

    Measured: From baseline through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2019
  2. Study start30 Jan 2019
  3. Primary completion13 Feb 2020
  4. Study completion9 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03890744
Sponsor's protocol ID
M18DMB
Status last verified
Mar 2019
First submitted
31 Jan 2019
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ModraDoc006/r in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Modra Pharmaceuticals at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, Denmark, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The objective response rate (ORR) (time frame: From baseline through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03890744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.

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