- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02688101
Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors
February 19, 2019 updated by: Collaborative Medicinal Development Pty Limited
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia
- Lifehouse Cancer Treatment Centre
-
-
Victoria
-
Heidelberg, Victoria, Australia
- Olivia Newton John Cancer Centre
-
Melbourne, Victoria, Australia
- Peter Maccallum Cancer Centre
-
Melbourne, Victoria, Australia
- Monash Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DpC
DpC capsules, administered orally
|
iron chelator
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Maximum DpC plasma concentration
|
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
|
DpC area under the plasma concentration vs. time curve
|
30 months
|
Number of patients with tumor responses as assessed by RECIST criteria
Time Frame: 36 months
|
number of tumor responses by RECIST criteria
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2016
Primary Completion (Actual)
October 26, 2017
Study Completion (Actual)
October 26, 2017
Study Registration Dates
First Submitted
January 25, 2016
First Submitted That Met QC Criteria
February 17, 2016
First Posted (Estimate)
February 23, 2016
Study Record Updates
Last Update Posted (Actual)
February 21, 2019
Last Update Submitted That Met QC Criteria
February 19, 2019
Last Verified
July 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CMD-2015-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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