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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01587703

NCT01587703
Completed Phase 1 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are 16 years of age or older at the time of signing the consent form.
  • You are able to understand and sign a consent form; if you are under 18, a parent or guardian must also give their consent.
  • You have been diagnosed with one of the following cancer types included in this trial: NUT Midline Carcinoma, Small Cell Lung Cancer (SCLC), Colorectal Cancer (CRC), Neuroblastoma (NB), Triple-Negative Breast Cancer (TNBC), Estrogen Receptor-positive Breast Cancer, Castration-Resistant Prostate Cancer (CRPC), Non-Small Cell Lung Cancer (NSCLC), or another solid tumor confirmed to have a specific gene change called MYCN amplification (confirm with trial site for which part of the trial applies to you).
  • Your cancer can be measured on scans according to standard guidelines (with some exceptions — confirm with trial site).
  • Any side effects from previous cancer treatments have mostly cleared up (no worse than mild, except for hair loss or nerve-related symptoms).
  • Your general health and ability to carry out daily activities meets the study's requirements (confirm with trial site for the specific score required for your cancer type).
  • Your blood, kidney, liver, heart, and thyroid are all working well enough to meet specific lab test requirements (confirm with trial site for exact values).
  • You are able to swallow tablets and do not have serious digestive problems that would stop your body from absorbing medication properly.
  • If you are a woman who could become pregnant, you agree to use reliable contraception during the study and for 7 months after your last dose, and you have a negative pregnancy test within 7 days before starting the trial.
  • If you are a woman who is breastfeeding, you agree to stop breastfeeding before starting treatment and for at least 28 days (or longer) after your last dose.
  • If you are a man, you agree to use contraception from your first dose until at least 16 weeks after your last dose, and to use condoms for 7 days after stopping treatment if your partner is or becomes pregnant.
  • If you have Castration-Resistant Prostate Cancer (CRPC), your prostate cancer has been confirmed by biopsy or lab testing, and you have been surgically or medically castrated for at least 8 weeks (Part 2 only).
  • If you have CRPC, your cancer has continued to grow despite standard treatments including specific hormone-blocking therapies (Part 2 only).
  • If you have CRPC, your testosterone level is very low (below a specific threshold) and your PSA level is at or above a certain level (confirm with trial site for exact values, Part 2 only).

Who may not be able to join:

  • Your cancer started in the brain or central nervous system, or is related to HIV or an organ transplant.
  • You have a known history of HIV, Hepatitis B, or Hepatitis C infection.
  • You have received another experimental cancer drug within the past 14 days or within 5 half-lives of that drug (whichever is longer), or have not recovered from its side effects.
  • You have had chemotherapy, radiation, targeted therapy, immunotherapy, or major surgery recently (specific waiting periods apply depending on the treatment — confirm with trial site).
  • You are currently taking blood-thinning medications (such as warfarin or heparin) at full treatment doses within 7 days before starting the trial; low-dose preventative blood thinners may be allowed (confirm with trial site).
  • You are currently taking medications that are not allowed during this trial, including any medicines known to affect the heart's electrical activity (QT prolongation) (confirm with trial site for the full list).
  • You have serious, uncontrolled health conditions such as unstable lung, liver, kidney, or heart disease, or serious mental health conditions that could affect your safety or ability to participate.
  • You have active or untreated cancer that has spread to the brain or spinal cord causing symptoms; previously treated and stable brain metastases may be allowed in some cases (confirm with trial site).
  • You have certain heart problems, including uncontrolled irregular heartbeats, significant problems with your heart's electrical system, a pacemaker, moderate-to-severe heart failure, or a heart attack, unstable chest pain, or

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
GlaxoSmithKline
Registry
clinicaltrials_gov
Start date
28 March 2012
Est. completion
13 April 2018

Where this trial is recruiting

🇦🇺 Australia 🇫🇷 France 🇳🇱 Netherlands 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD; Number of Participants With AEs and SAEs-Part 1 BID; Number of Participants With AEs and SAEs-Part 2; Number of Participants With Dose Reductions or Delays-Part 1 QD; Number of Participants With Dose Reductions or Delays-Part 1 BID; Number of Participants With Dose Reductions or Delays-Part 2; Number of Participants With Dose Reductions or Delays-Besylate Sub-study; Number of Participants Withdrawn Due to Toxicities-Part 1 QD; Number of Participants Withdrawn Due to Toxicities-Part 1 BID; Number of Pa...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov