Completed

A Phase 1 Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors

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What is being tested

DpC

Drug
Who is being recruted

Neoplasms

Over 18 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2016
See protocol details

Summary

Principal SponsorCollaborative Medicinal Development Pty Limited
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 11, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase 1 Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors
NCT02688101
Principal SponsorCollaborative Medicinal Development Pty Limited
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

18 inclusion criteria required to participate
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;
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11 exclusion criteria prevent from participating
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;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
DpC capsules, administered orally

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Lifehouse Cancer Treatment Centre

Sydney, AustraliaOpen Lifehouse Cancer Treatment Centre in Google Maps
Suspended

Olivia Newton John Cancer Centre

Heidelberg, Australia
Suspended

Monash Cancer Center

Melbourne, Australia
Suspended

Peter MacCallum Cancer Centre

Melbourne, Australia
Completed4 Study Centers