NCT02688101

Brief Summary

Multicenter, open-label, dose-escalation and pharmacokinetic study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
Last Updated

February 21, 2019

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

January 25, 2016

Last Update Submit

February 19, 2019

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Recommended phase 2 dose as determined by number of participants at each dose level with dose limiting toxicities

    Determine recommended phase 2 dose

    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

    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

    30 months

  • Number of patients with tumor responses as assessed by RECIST criteria

    36 months

Study Arms (1)

DpC

EXPERIMENTAL

DpC capsules, administered orally

Drug: DpC

Interventions

DpCDRUG

iron chelator

Also known as: Dp4cycH4mT
DpC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lifehouse Cancer Treatment Centre

Sydney, New South Wales, Australia

Location

Olivia Newton John Cancer Centre

Heidelberg, Victoria, Australia

Location

Monash Cancer Center

Melbourne, Victoria, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Neoplasms

Interventions

di-2-pyridylketone 4-cyclohexyl-4-methyl-3-thiosemicarbazone

Study Officials

  • Linda Mileshkin, MD

    Peter MacCallum Cancer Centre, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 23, 2016

Study Start

April 11, 2016

Primary Completion

October 26, 2017

Study Completion

October 26, 2017

Last Updated

February 21, 2019

Record last verified: 2017-07

Locations

AU(4)