Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.

Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.

Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.

Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.

Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.

Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors.

Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).

Taladegib

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The purpose of this study is to find a recommended dose level and schedule of dosing LY2940680 that can safely be taken by participants with advanced cancer. The study will also explore the changes in a cancer marker level in skin, hair follicles, buccal cells, and tumor cells. Finally, the study will help document any antitumor activity this drug may have.

Participants may include those who have previously received treatment with another hedgehog smoothened (Hh/Smo) inhibitor (excluding LY2940680).

A Study in Advanced Cancer

A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer

Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest tested dose that had \<33% probability of causing a DLT in Cycle 1 of Part A.

Pharmacokinetics (PK): 1.Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC\[0-∞\])

PK: Maximum Observed Drug Concentration (Cmax)

PK: Area Under the Plasma Concentration-time Curve from time Zero to 24 Hours (AUC\[0-24\]) of LSN3185556

PK: Maximum Observed Drug Concentration (Cmax) of LSN3185556

Clinical Benefit Rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions.

For each participant in Part C and D who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, PFS was censored at the date of last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

Eli Lilly and Company

All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly

Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 1

Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 2

Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 3

Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 4

Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 5

Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors.

Part C

Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).

Part D

Part A Cohort 2 : 100 mg taladegib administered orally QD on a 28-day cycle.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All participants who received at least one dose of study drug.

Part B of the study was not implemented as the estimated half-life was considered long enough for QD dosing.

Chief Medical Officer

Part A: Cohort 1 Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 2 Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 3 Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 4 Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.

Part A: Cohort 5 Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.

All Part A Participants

Part A participants who received at least one dose of study drug.

Recommended Phase 2 Dose: Maximum Tolerated Dose

Cycle 1, Day 1

Cycle 1, Day 15

50 milligram (mg) taladegib administered orally QD on a 28-day cycle.

50 mg Taladegib

100 mg taladegib administered orally QD on a 28-day cycle.

100 mg Taladegib

200 mg taladegib administered orally QD on a 28-day cycle.

200 mg Taladegib

400 mg taladegib administered orally QD on a 28-day cycle.

400 mg Taladegib

600 mg taladegib administered orally QD on a 28-day cycle.

600 mg Taladegib

All participants who received at least one dose of study drug and had evaluable PK data. All participants who received 400 mg taladegib were analyzed together.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])

Cycle 1,Day 15

PK: Time of Maximal Concentration (Tmax)

PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of LSN3185556

PK: Time of Maximal Concentration (Tmax) of LSN3185556

Number of Participants With Clinical Benefit Rate (Stable Disease [SD] + Partial Response [PR] + Complete Response [CR])

Part C and Part D participants who received at least one dose of study drug and had evaluable PFS data. Participants censored were Part C=8 and Part D=22. Per protocol, Part A data were not collected for PFS.

Part C and D: Progression Free Survival (PFS)

Overall Study

Symptoms and General Pathology

All Conditions

Constipation

Signs and Symptoms, Digestive

Pain and Symptom Management/Palliative Care Clinic outpatients, BC Cancer Agency, Vancouver Centre,

Pain and Symptom Management/Palliative Care Clinic outpatients, BC Cancer Agency, Centre for Southern Interior

Pain and Symptom Management/Palliative Care Clinic outpatients, BC Cancer Agency, Fraser Valley Centre

Pain and Symptom Management/Palliative Care Clinic outpatients, BC Cancer Agency, Vancouver Island Centre

Vancouver Coastal Cottage Hospice inpatients

Vancouver Coastal Richmond Palliative Care Program patients

Vancouver Coastal Lions Gate Palliative Care Unit inpatients

Providence Health St Paul's Hospital Palliative Care Unit inpatients

Providence Health Marion Hospice inpatients

Vancouver Island Health Authority Victoria Hospice inpatients

Fraser Health Burnaby Hospital Tertiary Palliative Care Unit inpatients

Philippa Dr Hawley, B.Med

The project's primary purpose is to establish a network of Hospice Palliative Care settings using a common and consistent method of assessing and documenting bowel functioning in order to be able to carry out future collaborative studies of constipation treatments. The secondary goal is to gather normative data on current bowel care function and outcomes of current treatments which can be used to determine sample size calculations for future controlled trials of bowel management protocols. In order to complete this goal the project requires a thorough assessment of current nursing practice in regard to bowel care.

Site assessment: Each site will be assessed as to their current bowel assessment and documentation methods, and their current bowel management strategy. Clinical practice leaders (nursing and physician) will be interviewed, and as many of the nurses as can be contacted will be asked to complete a brief questionnaire about bowel care at their site, with some focus groups being held in order to allow all staff to have input.

A retrospective chart review will be carried out to include at least 30 patients to establish the current documentation standard and outcomes.

The impact of bowel care on nursing practice will be assessed.

Intervention: As a result of the assessments at all the sites and in collaboration with the site leaders, the research team will devise a common reporting and documentation system which will enable systematic collection of bowel outcomes data. It is intended that the Victoria Bowel Performance Scale will be introduced, in combination with other reporting tools specific to bowel management. The tools may vary from site to site depending on the context of care, for example an inpatient unit will have differing requirements to an outpatient clinic. However the goal is for required outcome data to be retrievable from charts from all settings in a consistent, complete and reliable way.

Evaluation: Medical and nursing staff will be surveyed in the same way as in the initial assessment (interviews, questionnaires and focus groups), to assess the performance and acceptability of the modified reporting process. A second chart review will be undertaken when at least 30 patients have passed through the service. Outcomes from the chart reviews will be communicated back to care providers in order to give them feedback as to the quality of bowel care they are providing. Any further modifications to the data tracking system will be made so that by the end of the project the system is acceptable to all sites and functioning effectively, allowing the network of collaborating sites to proceed to the next step: clinical trials of different bowel care treatments.

Demographic data recorded will be that required to determine comparability of cohorts with respect to risk for constipation and will include the following variables.

* Age
* Gender
* Palliative Performance Status (PPSv2) on admission
* Diagnosis (if cancer, which tumour type)
* Major comorbid diagnoses
* Reason for admission
* Presence or absence of abdominal cancer
* Presence or absence of ascites
* Radiotherapy during admission (if yes, to abdomen or not)
* Medications taken during admission
* Duration of admission
* Number of days on bowel protocol
* Discharge or death

The primary outcome measures for bowel function for each patient will be the proportion of days with at least one bowel movement a day, and the proportion of patients with a bowel movement at least 40 % and at least 50% of days. The secondary outcome variables of the study will be use of enemas, suppositories or lactulose, and reported cramping and/or diarrhoea. Diarrhoea will be defined as either passage of watery stool at least once a day, or more than 3 bowel movements a day. These were the same outcome variables used in the docusate study. Sites will be grouped according to type of setting (hospice, PCU, home etc). Sites with very similar patients will be combined for statistical analysis (for example the two Vancouver residential hospices to which patients are referred through a common process and assigned to according to bed availability).

Acceptability of the BPS will be assessed through a combination of questionnaires and focus groups with staff at sites which elect to pilot it after reviewing the results of the initial assessment. Their responses will be analysed using qualitative methodology. Staff will also be asked at the end of the study whether or not they would prefer to continue to use the BPS for routine clinical assessment or to revert to their previous method.

The utility of the BPS as a suitable outcome measure for clinical trials of bowel management treatments will be explored by correlating the single item BPS score with the primary and secondary outcome variables. As scoring of the BPS is essentially a composite of multiple outcome variables, (bowel movement frequency, consistency, degree of sphincter control and associated symptoms such as cramping etc.) it is anticipated that the BPS will provide at least the same outcome information as the multiple individual variables, which are rarely fully documented. We hope that the BPS will provide more patient-centred and useful information to guide laxative treatment, as the tool is centred around the individual's "normal" bowel habit, rather than relying on arbitrarily defined norms. Data from all sites will be able to be pooled for this analysis.

The Bowel Research Collaborative Data Tracking System Implementation Study

Wyeth is now a wholly owned subsidiary of Pfizer

British Columbia Cancer Agency

Division Head of Palliative Care

Behaviors and Mental Disorders

Fatigue

Death

Quality of Life

Single-arm pilot study of a 7-week home/hospice-based Hatha yoga program for adolescent and young adults with non-curative cancer.

This is a 7-week home/hospice-based instructive Hatha yoga program (available on DVD) for adolescent and young adults diagnosed with a non-curative cancer. Participants will be asked to complete a minimum of one, 75-minute yoga session per week. The DVD package includes four discs that increase in difficulty over the course of the 7-week program. The DVD focuses on postures and breathing exercises. Participants will be asked to keep track of the number and duration of yoga sessions completed over the 7-week period.

Hatha Yoga

Rob Rutledge, MD, FRCPC

Adolescents and young adults who are living with cancer are not benefiting from the same age-appropriate physical and psychosocial care, as are children and older adults. As a result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a lack of age-appropriate care may be responsible for a deceased quality of life. Studies have also shown that physical activity is able to reduce many of the negative side-effects linked to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical activity that is both safe and manageable for cancer patients is yoga. The purpose of this study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha yoga program (available on DVD) in the adolescent and young adult non-curative cancer population. This study will also examine the ability of yoga to reduce cancer related side effects.

Yoga for Adolescent and Young Adult Non-Curative Cancer Patients

Impact of Yoga on Quality of Life for Adolescent and Young Adult Non-Curative Cancer Patients: A Pilot Study

Recruitment will be calculated by the number of patients who consent to participate, divided by the number of eligible participants recommended by the primary oncologist/physician.

Retention: Will be determined by reporting the number of participants who complete the baseline and post-program questionnaire and follow-up testing.

Adherence: Participants will be asked to record the number of yoga sessions performed each week. Overall adherence will be calculated by summing the actual number of sessions the participant engaged in, divided by the recommended number of sessions.

Safety: Any adverse events reported by the participant will be recorded.

Participants will be asked to complete the Functional Assessment of Chronic Illness Therapy - Palliative Care subscale (FACIT-Pal) and the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being subscale (FACIT-Sp) at baseline and post-intervention.

Dalhousie University

IWK Health Centre

Nova Scotia Health Authority

Rob Rutledge

Associate Professor, Department of Medicine, Dalhousie University

Nausea

Vomiting

Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.

Elasticated wrist bands without active bead.

Acupressure Wrist Bands (Sea-Bands)

Placebo wristbands

Paul Perkins, MB BCh MRCP

Paul Perkins, MB Bch MRCP

Pilot study completed - power calculation performed. Now formal double blind randomized study comparing active with placebo wristbands for nausea in palliative care patients to be carried out.

Terminally ill hospice in-patients suffering with nausea will be randomized to active or placebo acupressure bands. The study will last 3 days and they will be allowed to continue regular or have PRN anti-emetics during the study.

Assessors and patients will both be blinded to whether they patients are receiving active or placebo bands.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study in Advanced Cancer	NCT01226485	Advanced Cancer	Taladegib	18 Years -	Eli Lilly and Company
The Bowel Research Collaborative Data Tracking System Implementation Study	NCT00728975	Constipation		-	British Columbia Cancer Agency
Yoga for Adolescent and Young Adult Non-Curative Cancer Patients	NCT01901237	Advanced Cancer	Hatha Yoga	15 Years - 39 Years	Nova Scotia Health Authority
A Study in Advanced Cancer	NCT01226485	Advanced Cancer	Taladegib	18 Years -	Eli Lilly and Company
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study	NCT00550251	Nausea Vomiting	Acupressure Wri... Placebo wristba...	18 Years -	Sue Ryder Care

Spots Global Cancer Trial Database for terminal

Every month we try and update this database with for terminal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for terminal

Every month we try and update this database with for terminal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for terminal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.