NeoplasmsPhase 1NCT02688101
Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors
A Phase 1 study testing DpC in people with Neoplasms, run by Collaborative Medicinal Development Pty Limited at 4 sites in Australia.
Trial summary
Multicenter, open-label, dose-escalation and pharmacokinetic study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- DpC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesAustralia
- Study dates
- 11 Apr 2016to 26 Oct 2017
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to initiation of any study-specific procedures;
- Histologically or cytologically confirmed diagnosis of an advanced or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective, intolerable, or unacceptable for the patient;
- At least one measurable lesion as defined by RECIST v1.1, except for patients with castrate resistant prostate cancer, who may be enrolled with objective evidence of disease per PCWG2 criteria, and patients with ovarian cancer who may be enrolled without measurable disease but who are evaluable by CA125 per GCIC criteria;
- life expectancy at least 3 months;
- ECOG performance status 0-1;
- Adequate bone marrow reserve, cardiac, renal and liver function, defined by
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- absolute neutrophil count at least 1.5 x 10(9)/L;
- platelet count at least 100 x 10(9)/L;
- hemoglobin at least 9 g/dL;
- ferritin at least 50 ug/L;
- ECHO shows ejection fraction at least 50% and no evidence of cardiac dysfunction;
- creatinine clearance >50 mL/min (Cockcroft \& Gault formula);
- AST/ALT no more than 3 x ULN (5 x ULN if liver or bone involvement);
- serum albumin at least 28 g/L;
- INR no more than 1.5 x ULN;
- At least 3 weeks since chemotherapy, immunotherapy, hormone therapy, r other anticancer therapy or surgical intervention or at least 3 half-lie for monoclonal antibodies;
- Patients with castrate-resistant prostate cancer must maintain ongoing androgen deprivation therapy to provide serum testosterone <50 mg/dL;
- Patients receiving bisphosphonate or denosumab therapy must be on stable doses for at least 4 weeks before initiating study treatment.
Who cannot join
- Inability to swallow oral medications or presence of a GI disorder deemed to jeopardize intestinal absorption of DpC;
- Persistent grade >1 clinically significant toxicities related to prior anticancer treatment (except alopecia);
- Known primary CNS malignancy or CNS involvement (except for brain mets that have been treated and are stable and patient is off steroids);
- History of prior to concomitant malignancies (other than fully excised non-melanoma skin cancer, cured in situ cervical carcinoma, early stage bladder cancer or DCIS of breast) within 3 years of study entry;
- History of atrial fibrillation or evidence of atrial enlargement on baseline ECHO;
- History of hemoglobinopathy;
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- Current use of iron chelation therapy;
- Other serious illness or medial condition;
- Participation in another clinical trial or treatment with any investigational drug within 30 days prior to study entry;
- Current use of anticoagulants at therapeutic levels;
- Pregnant or breast-feeding patients and men and women of child-bearing potential not using effective contraception while on study treatment
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Olivia Newton John Cancer Centre
Heidelberg, Victoria
Monash Cancer Center
Melbourne, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria
Lifehouse Cancer Treatment Centre
Sydney, New South Wales
About this study
Official title: A Phase 1 Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors
Multicenter, open-label, dose-escalation and pharmacokinetic study.
Read the detailed description
Multicenter, open-label, phase 1 study of DpC administered orally to patients with advanced solid tumors. The study will be conducted in two parts. In the first phase successive cohorts of patients (3+3) will receive escalating doses of DpC until the maximum tolerated dose (MTD) is reached. MTD is based on tolerability observed during the first 28 days of treatment. The second part of the study involves treatment of expansion cohorts (10-15 patients each) in specific indications to confirm the tolerability of treatment at the recommended phase 2 dose and schedule and evaluate evidence of anti-tumor activity.
- Conditions
- Neoplasms
- Being tested
- DpC
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DpCDrug
Also called Dp4cycH4mT
iron chelator
| Study group | Role | What they receive |
|---|---|---|
| DpC | Experimental | DpC capsules, administered orally Receives: Drug: DpC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase 2 dose as determined by number of participants at each dose level with dose limiting toxicities
Determine recommended phase 2 dose
Measured: 36 months
Secondary outcomes (3)
Maximum DpC plasma concentration [Cmax] following dosing on Days 1 and 28 based on blood draws taken at 1, 2, 4, 8, and 24 hours after dosing
Maximum DpC plasma concentration
Measured: 30 months
Area under the DpC plasma concentration vs. time curve [AUC] following dosing on Days 1 and 28 based on blood draws taken at 1, 2, 4, 8, and 24 hours after dosing
DpC area under the plasma concentration vs. time curve
Measured: 30 months
Number of patients with tumor responses as assessed by RECIST criteria
number of tumor responses by RECIST criteria
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start11 Apr 2016
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collaborative Medicinal Development Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda Mileshkin, MD, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688101
- Sponsor's protocol ID
- CMD-2015-001
- Status last verified
- Jul 2017
- First submitted
- 25 Jan 2016
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02688101
- Acronym / sponsor ID
- CMD-2015-001
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Collaborative Medicinal Development Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, open-label, dose-escalation and pharmacokinetic study.
Detailed description
Multicenter, open-label, phase 1 study of DpC administered orally to patients with advanced solid tumors. The study will be conducted in two parts. In the first phase successive cohorts of patients (3+3) will receive escalating doses of DpC until the maximum tolerated dose (MTD) is reached. MTD is based on tolerability observed during the first 28 days of treatment. The second part of the study involves treatment of expansion cohorts (10-15 patients each) in specific indications to confirm the tolerability of treatment at the recommended phase 2 dose and schedule and evaluate evidence of anti-tumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DpC | Experimental | Drug: DpCDpC capsules, administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed informed consent prior to initiation of any study-specific procedures;
- Histologically or cytologically confirmed diagnosis of an advanced or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective, intolerable, or unacceptable for the patient;
- At least one measurable lesion as defined by RECIST v1.1, except for patients with castrate resistant prostate cancer, who may be enrolled with objective evidence of disease per PCWG2 criteria, and patients with ovarian cancer who may be enrolled without measurable disease but who are evaluable by CA125 per GCIC criteria;
- life expectancy at least 3 months;
- ECOG performance status 0-1;
Key exclusion criteria (11 listed)
- Inability to swallow oral medications or presence of a GI disorder deemed to jeopardize intestinal absorption of DpC;
- Persistent grade >1 clinically significant toxicities related to prior anticancer treatment (except alopecia);
- Known primary CNS malignancy or CNS involvement (except for brain mets that have been treated and are stable and patient is off steroids);
- History of prior to concomitant malignancies (other than fully excised non-melanoma skin cancer, cured in situ cervical carcinoma, early stage bladder cancer or DCIS of breast) within 3 years of study entry;
- History of atrial fibrillation or evidence of atrial enlargement on baseline ECHO;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DpCAlso: Dp4cycH4mTiron chelator | Drug | DpC |
Primary outcome
Recommended phase 2 dose as determined by number of participants at each dose level with dose limiting toxicities
Time frame: 36 months
Determine recommended phase 2 dose
3 secondary outcomes
Maximum DpC plasma concentration [Cmax] following dosing on Days 1 and 28 based on blood draws taken at 1, 2, 4, 8, and 24 hours after dosing
Time frame: 30 months
Area under the DpC plasma concentration vs. time curve [AUC] following dosing on Days 1 and 28 based on blood draws taken at 1, 2, 4, 8, and 24 hours after dosing
Time frame: 30 months
Number of patients with tumor responses as assessed by RECIST criteria
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Mileshkin, MD principal investigator
Peter MacCallum Cancer Centre, Australia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DpC in people with Neoplasms, run by Collaborative Medicinal Development Pty Limited at 4 sites in Australia.
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 11 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 21 Feb 2019. 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 Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Recommended phase 2 dose as determined by number of participants at each dose level with dose limiting toxicities (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2019.