Repotrectinib for Cancer, Advanced

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, NY
Cancer, Advanced+2 More
Repotrectinib - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called repotrectinib can be safely given with chemotherapy to children and young adults with advanced or metastatic solid tumors.

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Eligible Conditions

  • Cancer, Advanced
  • Solid Metastatic Tumor

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Repotrectinib will improve 2 primary outcomes in patients with Cancer, Advanced. Measurement will happen over the course of 8 weeks following the start of treatment.

1 year
Maximum tolerated dose (MTD) (phase I)
Week 8
incidence of Dose Limiting Toxicity (DLTs) (phase I)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

1 Treatment Group

Repotrectinib
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Repotrectinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

RepotrectinibPhase 1: Part A : TPX-0005 (Repotrectinib) will be given orally (without regard to food) once daily for 14 days, then increased to twice daily for remainder of cycles and concurrently administered with chemotherapy backbone described below. For patients less than 12 years old or less than 50kg, adult equivalent dosing (AED) will be used. Approximately 4-24 pediatric subjects will be enrolled into 2-4 dose levels (pending if DL-1 or DL-1b are utilized), with maximum of 6 subjects per dose level according to the 'rolling 6' design. Starting dose of TPX-0005 (Repotrectinib) will begin at dose level (DL) 1. Part B (combination therapy; patients less than 12 years old or ≤ 50kg): For 6 additional patients, a safety run-in will be conducted with TPX-0005 (Repotrectinib) and chemotherapy.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Cancer, Advanced or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Myelosuppressive chemotherapy: Last dose was given at least 21 days before the start date for protocol therapy.
Biologic (anti-neoplastic agent including retinoids): Last dose given at least 7 days prior to the start date for protocol therapy.
Monoclonal antibodies: Last dose of any monoclonal antibodies must have received at least 7 days or 3 half-lives, whichever is longer, prior to the start date for protocol therapy.
Immunotherapy (ex: tumor vaccine): Patient is eligible after 42 days of completion. Steroids are excluded from inclusion in immunotherapy.
Radiation Therapy: Patients must not have received radiation for a minimum of two weeks prior to study enrollment for small port. If extensive bone marrow radiation, at least 42 days must have elapsed.
Palliative radiotherapy on study is permitted for the treatment of painful bony lesions providing the lesions were known at the time of study entry and the Investigator clearly indicates that the need for palliative radiotherapy is not indicative of disease progression. In view of the current lack of data about the interaction of repotrectinib with radiotherapy, repotrectinib treatment should be interrupted during palliative radiotherapy, stopping 1 day before palliative radiotherapy and resuming treatment 1 day after completion of palliative radiotherapy and recovery from any acute radiation toxicities to baseline.
Hematopoietic Stem Cell Transplant (HSCT): Patients are eligible 12 weeks after date of autologous hematopoietic stem cell infusion following myeloablative therapy (timed from first day of this protocol therapy). Patients who have received an autologous hematopoietic stem cell infusion to support non- myeloablative therapy (such as ^131 I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility.
^131 I-MIBG therapy: A minimum of 6 weeks must have elapsed after ^131 I-MIBG therapy prior to start of protocol therapy.
Growth factors: Patients are eligible 14 days after last dose of long-acting growth factor (ex: peg-GCSF) or 7 days after short acting growth factor.
Any investigational agent or anticancer therapy other than chemotherapy and not otherwise noted: Not within 2 weeks prior to planned start of TPX-0005 (Repotrectinib) or 5 half-lives, whichever is shorter. Full recovery of clinically significant toxicities from that therapy must be evident.

Patient Q&A Section

What causes cancer?

"The most accepted theory today for cancer cause is the “tut” or "taboo" of a demon who destroys mankind at some point in the past. But that isn't true for most people. According to the World Health Organization's latest data, cancer, in 2015, was the cause of 7.7 million deaths worldwide, up from 2.4 million in 1990. And worldwide cancer death rates have dropped from 2.1 million in 1990 and 7.4 million in 2000. According to one study, “tobacco, alcohol, obesity, UV rays, and diet are just a few factors that have been shown to be highly associated with some cancers." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"The use of cancer treatment based on the theory that this disease is a deficiency of vitamin B17 is not justified and is based on quackery." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"This article discusses the various entities, aspects and perspectives on cancer and its differentiating characteristics. It starts with a short description of cancer and its various subtypes and continues with defining cancer from a molecular/systems perspective, which also illustrates how cancer evolves by combining various tumor-host interactions." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Most cancers are asymptomatic, i.e. symptom-free. Symptoms may arise as a result of increased intrathoracic pressure on the brain from primary tumour growth, metastasis or secondary tumours, or as a result of the spread of cancer tumour or metastases." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"A minority of common cancer treatments are used by > 50% of patients with different types of cancer. However, the majority of patients with each specific cancer type are prescribed a common cancer treatment. Recent findings may reflect common treatments in clinical practice, provider preferences, and limitations in health information retrieval. Clin Cancer Res;22(16); 3990-4001. ©2016 AACR." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"At the time of diagnosis, it is estimated that 940,000 people develop cancer annually and 780,000 die of cancer. A year after cancer diagnosis, the number of people diagnosed with cancer continues to rise at a rate of 6.6%, but the number of people still living a full life year after cancer diagnosis (that is, cancer-free) continues to decrease at a rate of 3.1%. This means that in a year, more people die in the United States than is diagnosed with cancer; however, our data do not reflect the full burden of cancer because individuals who die without ever knowing of cancer receive zero cancer-specific survivorship." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cancer?

"The average age of diagnosis for cancer is 66.7 years, and the average age of death is 71.6 years. The overall survival rate is 68.2% and the mortality rate is 12.7%. This is consistent with the average life span, since the average age of death for the Netherlands is 79.3 years and the average life span is about 81.7 years." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in repotrectinib for therapeutic use?

"The most recent data from studies using current or previous repotrectinib in advanced cancer are shown in Table 6. Note that none of these studies is comparing repotrectinib to standard cytotoxic chemotherapy.\n\n- "" - Anonymous Online Contributor

Unverified Answer

How serious can cancer be?

"Cancer is deadly, it can kill fast, and it can kill young – even when detected early thanks to modern treatment methods. The only way is to get the cancer cured. And even when it is cured, the risks of recurrence and reoccurrence, of regrowth and re-regrowth must be faced." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"The familial risk for cancers is higher for cancers with higher genetic heterogeneity. This suggests that for certain types of cancer, a better understanding of their etiology may involve consideration of genetic heterogeneity as measured by the clustering of specific cancer genes or genetic markers in families as well as other forms of population genetic analyses." - Anonymous Online Contributor

Unverified Answer

Does repotrectinib improve quality of life for those with cancer?

"The use of repotrectinib resulted in an improvement in the QoL of people with cancer. The use of repotrectinib for those with non-small cell lung cancer resulted in an improvement in the QoL score of those with both advanced and metastatic non-small cell lung cancer." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving repotrectinib?

"There were two phase I trials. The more recent is being conducted at the same site. There were no results available as of yet to show which side effects there would be, which dose and duration, or the safety of the drug. A second trial is under way to determine the antitumor activity of the compound. No results as of May 2016. This drug is being developed by Aptus Therapeutics, a biotechnology company based in Cambridge, UK, which uses its technology to identify and evaluate potential medicines with therapeutic action in a wide range of disease states." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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