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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02688101




Registration number
NCT02688101
Ethics application status
Date submitted
25/01/2016
Date registered
23/02/2016
Date last updated
21/02/2019

Titles & IDs
Public title
Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors
Scientific title
A Phase 1 Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
CMD-2015-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DpC

Experimental: DpC - DpC capsules, administered orally


Treatment: Drugs: DpC
iron chelator

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recommended phase 2 dose as determined by number of participants at each dose level with dose limiting toxicities - Determine recommended phase 2 dose
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
30 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
30 months
Secondary outcome [3] 0 0
Number of patients with tumor responses as assessed by RECIST criteria - number of tumor responses by RECIST criteria
Timepoint [3] 0 0
36 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Lifehouse Cancer Treatment Centre - Sydney
Recruitment hospital [2] 0 0
Olivia Newton John Cancer Centre - Heidelberg
Recruitment hospital [3] 0 0
Monash Cancer Center - Melbourne
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Collaborative Medicinal Development Pty Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Multicenter, open-label, dose-escalation and pharmacokinetic study.
Trial website
https://clinicaltrials.gov/show/NCT02688101
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Linda Mileshkin, MD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications