Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in P… (NCT04299048) | Clinical Trial Compass
CompletedPhase 1
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
United States11 participantsStarted 2020-11-17
Plain-language summary
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented histologic or cytologic diagnosis of advanced metastatic NSCLC, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer.
* Cachexia, defined by BMI \<20 kg/m2 with involuntary weight loss of \>2% within 6 months prior to screening or Involuntary weight loss of \>5% within 6 months prior to screening irrespective of BMI or If medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.;
* Will receive the following for non-small cell lung cancer:
* a platinum + pemetrexed ± pembrolizumab or
* a platinum + nab paclitaxel or paclitaxel ± pembrolizumab or
* pembrolizumab alone
* Will receive the following for pancreatic cancer:
* FOLFIRINOX or
* Nab-Paclitaxel + Gemcitabine
* Gemcitabine
* Will receive the following for colorectal cancer:
* FOLFOX +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
* FOLFIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
* FOLFOXIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
* Pembrolizumab for MSI-H • Will be entering the study at the first or second cycle of their current course of anti-cancer treatment/ therapy.
* Adequate renal and liver function.
* Signed informed consent.
Exclusion Criteria:
* All other forms of cancers not specified above unless currently considered cured (\>5 years without evidence of recurrence).
* Planned radiation therapy as part of the primary anti-tumor therapy reg…
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From Day 1 up to Week 24
2
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Timeframe: From Day 1 up to Week 24
3
Number of Participants With Post-Baseline Vital Signs Abnormalities
Timeframe: From Day 1 up to Week 24
4
Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities