Clinical trial · Interventional
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
A PHASE 1B, 12-WEEK, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING REPEATED SUBCUTANEOUS ADMINISTRATIONS OF PF-06946860 IN PATIENTS WITH CANCER AND CACHEXIA
NCT04299048CI-TRIAL-00072280completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-06946860 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PF-06946860
- description
- subcutaneous injection
- interventionNames
- Drug: PF-06946860
Primary outcomes (4)
- measure
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- timeFrame
- From Day 1 up to Week 24
- description
- An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An AE was considered an TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 regimen. However, localized radiation therapy for symptomatic relief is permitted * Cachexia caused by other reasons: Severe COPD requiring use of home O2, heart failure or AIDS. * known symptomatic brain metastases requiring steroids. * Active hepatitis B or C virus. * Confirmed positive HIV test. * Current active reversible causes of decreased food intake. * Receiving tube feedings or parenteral nutrition at Screening. * Elevated blood pressure that cannot be controlled by medications. * Women who are pregnant or breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.